Four produce importers were issued Warning Letters from FDA for issues with the FSVP.
Did not develop an FSVP for any of the foods you import, including each of the following foods:
Enoki Mushroom imported from (b)(4);
King Oyster Mushroom imported from (b)(4);
Enoki Mushroom imported from (b)(4).
Paso Real Produce LLC of Pharr, TX
Did not develop an FSVP for any of the foods you import, including each of the following:
Avocados imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
did not develop an FSVP for any of the foods that you import, including each of the following foods:
Persian limes imported from (b)(4), located in (b)(4)
Rambutan imported from (b)(4), located in (b)(4)
Thai banana imported from (b)(4), located in (b)(4)
Green Day Produce, Inc. of Vernon, CA
did not evaluate your foreign suppliers of covered produce for compliance with the Produce Safety Rule (PSR), 21 CFR part 112. During our inspection, you provided FSVPs for your seafood mushrooms and oyster mushrooms imported from (b)(4) and for your (b)(4) mangos imported from (b)(4). Seafood mushrooms, oyster mushrooms, and mangos are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation.
Items noted
Seafood Mushrooms imported from (b)(4)
Oyster Mushrooms imported from (b)(4)
Taiwanese Mangos imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/future-best-trading-inc-689940-10102024
Future Best Trading Inc.
MARCS-CMS 689940 — October 10, 2024
Recipient:
Zhenwei Wang
Chief Executive Officer
Future Best Trading Inc.
5917 Oak Ave, Unit 379
Temple City, CA 91780
United States
Issuing Office:
Division of West Coast Imports
United States
October 10, 2024
WARNING LETTER
Re: CMS #689940
Dear Mr. Wang:
Zhenwei Wang
Chief Executive Officer
Future Best Trading Inc.
5917 Oak Ave, Unit 379
Temple City, CA 91780
United States
Issuing Office:
Division of West Coast Imports
United States
October 10, 2024
WARNING LETTER
Re: CMS #689940
Dear Mr. Wang:
On July 3 and 5, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of Future Best Trading Inc. located at 1400 E. Olympic Blvd., Los Angeles, CA 90021. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
This for-cause inspection was initiated due to FDA laboratory findings of Listeria monocytogenes in a sample of fresh Enoki Mushrooms from your foreign supplier, (b)(4) and imported by your company on May 6, 2024. FDA collected a sample on May 22, 2024, and confirmed the presence of Listeria monocytogenes through lab analysis on June 3, 2024. On August 2, 2024, you destroyed this shipment under FDA supervision after receipt of the FDA Notice of Action which notified you that we analyzed a sample collected from the shipment, detected Listeria monocytogenes, and determined the enoki mushrooms were adulterated under section 402 of the FD&C Act.
During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers as indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your responses to the Form FDA 483a, dated July 22 and July 24, 2024, in which you provided several documents. However, you did not provide an explanation of these documents, including how they would meet FSVP requirements. You provided two documents that appear to be general procedures for your import activities, labeled, “FSVP for Enoki and King Oyster” and “FSVP for Mushroom from (b)(4)”. These documents are undated and do not document a review or approval by an individual qualified to perform FSVP activities. (21 CFR 1.503(a)).. You also provided a document labeled “FSVP-(b)(4),” which includes audit certificates and photographs of several mushroom products from different manufacturers, including (b)(4). You also provided various other documents in a foreign language without English translation, and a document titled “(b)(4),” which appears to be the supplier’s food safety improvement plan. While some of the documents you provided could be relevant to development of an FSVP, you did not explain how they would apply to your FSVP program. Therefore, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). As our investigator explained, the FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate your foreign supplier’s performance (21 CFR 1.505), and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements. To the extent you intend to use any of these records to meet your obligations under the FSVP regulation, you did not demonstrate that you reviewed or assessed any of the documents.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:
Enoki Mushroom imported from (b)(4);
King Oyster Mushroom imported from (b)(4);
Enoki Mushroom imported from (b)(4).
You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
In addition, (b)(3)(A).
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A).
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place all food you import into the United States on detention without physical examination (DWPE). You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
In addition, we offer the following comments: 21 CFR 1.508(a) requires that you must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act and the implementing regulations, or produces food that is adulterated under section 402 of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the foreign supplier verification activities conducted under 21 CFR 1.506 or 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include notifying the foreign supplier of the problem and requesting documentation of corrective actions taken by the foreign supplier or discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with 21 CFR 1.508(a).
In your response to Form FDA 483a, you provided a document titled “(b)(4),” which appears to be your foreign supplier’s food safety improvement plan to address FDA’s findings of Listeria monocytogenes in a sample of the fresh Enoki Mushrooms you imported from them. During our inspection, you told our investigator that you spoke to your supplier about its investigation into the source of the Listeria monocytogenes in their facility. You also stated you may start (b)(4), in the future. The document you provided in your response and the activities you described at the inspection may be part of corrective actions, pursuant to 21 CFR 1.508. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a). You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
This for-cause inspection was initiated due to FDA laboratory findings of Listeria monocytogenes in a sample of fresh Enoki Mushrooms from your foreign supplier, (b)(4) and imported by your company on May 6, 2024. FDA collected a sample on May 22, 2024, and confirmed the presence of Listeria monocytogenes through lab analysis on June 3, 2024. On August 2, 2024, you destroyed this shipment under FDA supervision after receipt of the FDA Notice of Action which notified you that we analyzed a sample collected from the shipment, detected Listeria monocytogenes, and determined the enoki mushrooms were adulterated under section 402 of the FD&C Act.
During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers as indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your responses to the Form FDA 483a, dated July 22 and July 24, 2024, in which you provided several documents. However, you did not provide an explanation of these documents, including how they would meet FSVP requirements. You provided two documents that appear to be general procedures for your import activities, labeled, “FSVP for Enoki and King Oyster” and “FSVP for Mushroom from (b)(4)”. These documents are undated and do not document a review or approval by an individual qualified to perform FSVP activities. (21 CFR 1.503(a)).. You also provided a document labeled “FSVP-(b)(4),” which includes audit certificates and photographs of several mushroom products from different manufacturers, including (b)(4). You also provided various other documents in a foreign language without English translation, and a document titled “(b)(4),” which appears to be the supplier’s food safety improvement plan. While some of the documents you provided could be relevant to development of an FSVP, you did not explain how they would apply to your FSVP program. Therefore, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). As our investigator explained, the FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate your foreign supplier’s performance (21 CFR 1.505), and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements. To the extent you intend to use any of these records to meet your obligations under the FSVP regulation, you did not demonstrate that you reviewed or assessed any of the documents.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:
Enoki Mushroom imported from (b)(4);
King Oyster Mushroom imported from (b)(4);
Enoki Mushroom imported from (b)(4).
You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
In addition, (b)(3)(A).
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A).
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place all food you import into the United States on detention without physical examination (DWPE). You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
In addition, we offer the following comments: 21 CFR 1.508(a) requires that you must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act and the implementing regulations, or produces food that is adulterated under section 402 of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the foreign supplier verification activities conducted under 21 CFR 1.506 or 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include notifying the foreign supplier of the problem and requesting documentation of corrective actions taken by the foreign supplier or discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with 21 CFR 1.508(a).
In your response to Form FDA 483a, you provided a document titled “(b)(4),” which appears to be your foreign supplier’s food safety improvement plan to address FDA’s findings of Listeria monocytogenes in a sample of the fresh Enoki Mushrooms you imported from them. During our inspection, you told our investigator that you spoke to your supplier about its investigation into the source of the Listeria monocytogenes in their facility. You also stated you may start (b)(4), in the future. The document you provided in your response and the activities you described at the inspection may be part of corrective actions, pursuant to 21 CFR 1.508. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a). You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations.
You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Lydia S. Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #689940 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/paso-real-produce-llc-691665-10012024
Paso Real Produce LLC
MARCS-CMS 691665 — October 01, 2024
Recipient:
Mr. Salvador Pulido Novoa
Owner/President
Paso Real Produce LLC
1301 W. Capote Central Ave.
Pharr, TX 78577
United States
salvador@pasorealproduce.com
Issuing Office:
Division of Southwest Imports
United States
October 1, 2024
WARNING LETTER
Re: CMS # 691665
Dear Mr. Pulido,
On August 9-14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Paso Real Produce, LLC located at 1301 W. Capote Central Ave., Pharr, TX 78577. We also conducted inspections on September 10, 2021 and April 4-5, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We have not received your response to the Form 483a issued on August 14, 2024.
Your significant violation of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods you import, including each of the following:
Avocados imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
This is a repeat observation from the previous inspections conducted on September 10, 2021 and April 4-5, 2023
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the foods you import which appear to be in violation of section 805. We may place these foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at: http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX, 75202. If you have any questions regarding this letter, or wish to provide your response via email, you may contact Rosa Linda Santos at rosa.santos@fda.hhs.gov. Please reference CMS #691665 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Program Division Director
Division of Southwest Imports
1201 Main Street, Suite 7200
Dallas, TX 75202
Cc: Paso Real Produce LLC
1301 W. Capote Central Ave.
Pharr, TX 78577
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jc-finest-produce-inc-680500-06242024
WARNING LETTER
JC Finest Produce Inc
MARCS-CMS 680500 — June 24, 2024
Recipient:
Mr. Cesar W. Castaneda
JC Finest Produce Inc
2540 E Meadows Blvd Apt C
Mesquite, TX 75150-2461
United States
Issuing Office:
Division of Southwest Imports
United States
June 24, 2024
WARNING LETTER
Re: CMS# 680500
Dear Mr. Cesar W. Castaneda:
On March 7 through March 8, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of JC Finest Produce Inc. located at 2540 E Meadows Blvd Apt C Mesquite, TX 75150-2461. We also conducted an inspection on July 26 through August 07, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a issued on March 8, 2024.
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods that you import, including each of the following foods:
Persian limes imported from (b)(4), located in (b)(4)
Rambutan imported from (b)(4), located in (b)(4)
Thai banana imported from (b)(4), located in (b)(4)
You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
(b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A)
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on Detention Without Physical Examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Juan Daniel Garza III, Compliance Officer, US FDA, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact CO Garza via email at juan.garza@fda.hhs.gov. Please reference CMS# 680500 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Division Director
Division of Southwest Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-day-produce-inc-679085-07112024
WARNING LETTER
Green Day Produce, Inc.
MARCS-CMS 679085 — July 11, 2024
Recipient:
William Chy
Owner/Operating Officer
Green Day Produce, Inc.
5801 Alcoa Ave
Vernon, CA 90058-2026
United States
Issuing Office:
Division of West Coast Imports
United States
July 11, 2024
WARNING LETTER
Re: CMS # 679085
Dear Mr. Chy:
On February 7 through February 12, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Green Day Produce, Inc. located at 5801 Alcoa Ave., Vernon, CA. We also conducted inspections on August 24, 2023 and February 9, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act- fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans- and-animals
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import:
Seafood Mushrooms imported from (b)(4)
Oyster Mushrooms imported from (b)(4)
Taiwanese Mangos imported from (b)(4)
Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response date February 27, 2024, and we address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not evaluate your foreign supplier’s performance and the risk posed by the foods you import, including the foreign supplier’s compliance with applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, in accordance with 21 CFR 1.505(a)(1)(iii).
Specifically, you did not evaluate your foreign suppliers of covered produce for compliance with the Produce Safety Rule (PSR), 21 CFR part 112. During our inspection, you provided FSVPs for your seafood mushrooms and oyster mushrooms imported from (b)(4) and for your (b)(4) mangos imported from (b)(4). Seafood mushrooms, oyster mushrooms, and mangos are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation. You provided a document identified as “Produce Safety Rule and FSVP Standards”. However, this document provides definitions and general procedures, and it does not demonstrate your evaluation of your foreign supplier’s performance and the risk posed by the foods you import, including applicable FDA food safety regulations.
In addition, other FSVP documents you provided do not adequately demonstrate that you considered your foreign supplier’s performance and risk posed by the foods you import. In your written response dated February 27, 2024, you provided documents identified as “Supplier FSVP Verification” for oyster and seafood mushrooms from (b)(4) and a “Supplier Risk Assessment” for (b)(4) mangos from (b)(4). These documents describe the business activity of (b)(4) as “selling and labelling goods to domestic market and foreign market” and the business activity of (b)(4). as a “packhouse”. We note that these entities do not appear to meet the definition of a foreign supplier. A foreign supplier is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, as defined in 21 CFR 1.500.
2. Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c).
Specifically, for your oyster mushrooms and seafood mushrooms from (b)(4) you provided a third-party audit report identified as “(b)(4) audit report” ((b)(4)). Your oyster and seafood mushrooms are “covered produce” under FDA’s produce safety regulation (as defined in 21 CFR 112.3), however, the third-party audit of (b)(4) did not consider whether your foreign supplier follows the procedures set forth in that regulation to significantly minimize or prevent biological hazards in the covered produce.
In your written response dated February 27, 2024, you provided a document identified as “Food Safety Plan for Produce Supply Chain at Green Day Inc.”, created in August 2023. We are unable to evaluate the adequacy of your response. We note that this document appears to provide a general hazard analysis and other standards pertaining to your importation of produce and it does not describe particular products or foreign suppliers of those products.
You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
In addition, we offer the following comment:
We acknowledge your corrective action to (b)(4) importation of enoki mushrooms from the foreign supplier, (b)(4). If you choose to resume importing from this supplier in the future, you are required to re-evaluate the foreign supplier's performance and the risk posed by a food as required by 21 CFR 1.505. In addition, it is your responsibility to promptly reevaluate your suppliers when you become aware of new information concerning your foreign suppliers’ performance and the risk posed by a food, and the reevaluation must be documented.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE). You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to:
Food and Drug Administration
Attention: Dan Simonsen, Compliance Officer
Division of West Coast Imports
1 World Trade Center, Ste. 300
Long Beach, CA 90831
If you have any questions regarding this letter, you may contact Compliance Officer Dan Simonsen via email at Daniel.Simonsen@fda.hhs.gov. Please reference CMS # 679085 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
Please send your reply to Food and Drug Administration, Attention: Lydia S. Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #689940 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/paso-real-produce-llc-691665-10012024
Paso Real Produce LLC
MARCS-CMS 691665 — October 01, 2024
Recipient:
Mr. Salvador Pulido Novoa
Owner/President
Paso Real Produce LLC
1301 W. Capote Central Ave.
Pharr, TX 78577
United States
salvador@pasorealproduce.com
Issuing Office:
Division of Southwest Imports
United States
October 1, 2024
WARNING LETTER
Re: CMS # 691665
Dear Mr. Pulido,
On August 9-14, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Paso Real Produce, LLC located at 1301 W. Capote Central Ave., Pharr, TX 78577. We also conducted inspections on September 10, 2021 and April 4-5, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We have not received your response to the Form 483a issued on August 14, 2024.
Your significant violation of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods you import, including each of the following:
Avocados imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
Limes imported from (b)(4) located in (b)(4)
This is a repeat observation from the previous inspections conducted on September 10, 2021 and April 4-5, 2023
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the foods you import which appear to be in violation of section 805. We may place these foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at: http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX, 75202. If you have any questions regarding this letter, or wish to provide your response via email, you may contact Rosa Linda Santos at rosa.santos@fda.hhs.gov. Please reference CMS #691665 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Program Division Director
Division of Southwest Imports
1201 Main Street, Suite 7200
Dallas, TX 75202
Cc: Paso Real Produce LLC
1301 W. Capote Central Ave.
Pharr, TX 78577
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jc-finest-produce-inc-680500-06242024
WARNING LETTER
JC Finest Produce Inc
MARCS-CMS 680500 — June 24, 2024
Recipient:
Mr. Cesar W. Castaneda
JC Finest Produce Inc
2540 E Meadows Blvd Apt C
Mesquite, TX 75150-2461
United States
Issuing Office:
Division of Southwest Imports
United States
June 24, 2024
WARNING LETTER
Re: CMS# 680500
Dear Mr. Cesar W. Castaneda:
On March 7 through March 8, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of JC Finest Produce Inc. located at 2540 E Meadows Blvd Apt C Mesquite, TX 75150-2461. We also conducted an inspection on July 26 through August 07, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a issued on March 8, 2024.
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods that you import, including each of the following foods:
Persian limes imported from (b)(4), located in (b)(4)
Rambutan imported from (b)(4), located in (b)(4)
Thai banana imported from (b)(4), located in (b)(4)
You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
(b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A)
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on Detention Without Physical Examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Juan Daniel Garza III, Compliance Officer, US FDA, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact CO Garza via email at juan.garza@fda.hhs.gov. Please reference CMS# 680500 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Todd Cato
Division Director
Division of Southwest Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-day-produce-inc-679085-07112024
WARNING LETTER
Green Day Produce, Inc.
MARCS-CMS 679085 — July 11, 2024
Recipient:
William Chy
Owner/Operating Officer
Green Day Produce, Inc.
5801 Alcoa Ave
Vernon, CA 90058-2026
United States
Issuing Office:
Division of West Coast Imports
United States
July 11, 2024
WARNING LETTER
Re: CMS # 679085
Dear Mr. Chy:
On February 7 through February 12, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Green Day Produce, Inc. located at 5801 Alcoa Ave., Vernon, CA. We also conducted inspections on August 24, 2023 and February 9, 2023. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act- fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans- and-animals
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import:
Seafood Mushrooms imported from (b)(4)
Oyster Mushrooms imported from (b)(4)
Taiwanese Mangos imported from (b)(4)
Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response date February 27, 2024, and we address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not evaluate your foreign supplier’s performance and the risk posed by the foods you import, including the foreign supplier’s compliance with applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, in accordance with 21 CFR 1.505(a)(1)(iii).
Specifically, you did not evaluate your foreign suppliers of covered produce for compliance with the Produce Safety Rule (PSR), 21 CFR part 112. During our inspection, you provided FSVPs for your seafood mushrooms and oyster mushrooms imported from (b)(4) and for your (b)(4) mangos imported from (b)(4). Seafood mushrooms, oyster mushrooms, and mangos are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation. You provided a document identified as “Produce Safety Rule and FSVP Standards”. However, this document provides definitions and general procedures, and it does not demonstrate your evaluation of your foreign supplier’s performance and the risk posed by the foods you import, including applicable FDA food safety regulations.
In addition, other FSVP documents you provided do not adequately demonstrate that you considered your foreign supplier’s performance and risk posed by the foods you import. In your written response dated February 27, 2024, you provided documents identified as “Supplier FSVP Verification” for oyster and seafood mushrooms from (b)(4) and a “Supplier Risk Assessment” for (b)(4) mangos from (b)(4). These documents describe the business activity of (b)(4) as “selling and labelling goods to domestic market and foreign market” and the business activity of (b)(4). as a “packhouse”. We note that these entities do not appear to meet the definition of a foreign supplier. A foreign supplier is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, as defined in 21 CFR 1.500.
2. Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c).
Specifically, for your oyster mushrooms and seafood mushrooms from (b)(4) you provided a third-party audit report identified as “(b)(4) audit report” ((b)(4)). Your oyster and seafood mushrooms are “covered produce” under FDA’s produce safety regulation (as defined in 21 CFR 112.3), however, the third-party audit of (b)(4) did not consider whether your foreign supplier follows the procedures set forth in that regulation to significantly minimize or prevent biological hazards in the covered produce.
In your written response dated February 27, 2024, you provided a document identified as “Food Safety Plan for Produce Supply Chain at Green Day Inc.”, created in August 2023. We are unable to evaluate the adequacy of your response. We note that this document appears to provide a general hazard analysis and other standards pertaining to your importation of produce and it does not describe particular products or foreign suppliers of those products.
You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
In addition, we offer the following comment:
We acknowledge your corrective action to (b)(4) importation of enoki mushrooms from the foreign supplier, (b)(4). If you choose to resume importing from this supplier in the future, you are required to re-evaluate the foreign supplier's performance and the risk posed by a food as required by 21 CFR 1.505. In addition, it is your responsibility to promptly reevaluate your suppliers when you become aware of new information concerning your foreign suppliers’ performance and the risk posed by a food, and the reevaluation must be documented.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE). You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to:
Food and Drug Administration
Attention: Dan Simonsen, Compliance Officer
Division of West Coast Imports
1 World Trade Center, Ste. 300
Long Beach, CA 90831
If you have any questions regarding this letter, you may contact Compliance Officer Dan Simonsen via email at Daniel.Simonsen@fda.hhs.gov. Please reference CMS # 679085 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
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