Warning Letters were issued to two CA food importers.
New India Bazar, Inc., Milpitas, CA received an inspection in response to the recent recall event associated with MAGGI Noodles imported by the company. Specifically, the product labels imported from the foreign supplier were examined and found to contain undeclared allergens. The label listed “hydrolyzed groundnut protein” as an ingredient without clarifying that this referred to peanuts, and without declaring peanuts on the product label.
In the FSVP inspection, the company did not develop an FSVP for the foods from the foreign suppliers indicated in the attached FSVP011 list, as well as the following foods: Masala Munch Snack, imported from (b)(4), located in India Chat Papri, imported from (b)(4), located in India Gujarati Chavana (snack), imported from (b)(4), located in India
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/la-sucursal-produce-inc-673621-03012024
La Sucursal Produce Inc.
MARCS-CMS 673621 — MARCH 01, 2024
Recipient:
Jose C. Leon Beltran
CEO
La Sucursal Produce Inc.
1318 E 7th St, Ste 40
Los Angeles, CA 90021-1125
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
March 1, 2024
RE: CMS # 673621
Dear Mr. Beltran:
On October 25, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at La Sucursal Produce Inc. located at 1318 E 7th St, Ste 40, Los Angeles, CA 90021-1125. We also conducted an inspection on May 03, 2019 and August 16, 2022. 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 United States 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 were 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 a response to the FDA 483a issued on October 25, 2023.
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, maintain, and follow an FSVP for any of the foods that you import, including:
Husk Tomato imported from (b)(4) in (b)(4);
Green Onion imported from (b)(4) in (b)(4);
Peas imported from (b)(4) 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.
In addition, FDA has determined that your facility located at 1318 E 7th St, Ste 40, Los Angeles, CA 90021 is subject to the food facility registration requirement in section 415 of the FD&C Act (21 U.S.C. 350d) and our implementing regulations at 21 CFR part 1, subpart H. During the most recent inspection, you were advised of this requirement. Our records indicate that, to date, your facility has not been registered with FDA. Failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)).
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.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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. We may place the foods you import 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 these violations. You should include in your response documentation and information that will 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 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: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831.
If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 673621 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports Acting PDD
WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-india-bazar-inc-677343-04012024
New India Bazar, Inc.
MARCS-CMS 677343 — APRIL 01, 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, maintain, and follow an FSVP for any of the foods that you import, including:
Husk Tomato imported from (b)(4) in (b)(4);
Green Onion imported from (b)(4) in (b)(4);
Peas imported from (b)(4) 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.
In addition, FDA has determined that your facility located at 1318 E 7th St, Ste 40, Los Angeles, CA 90021 is subject to the food facility registration requirement in section 415 of the FD&C Act (21 U.S.C. 350d) and our implementing regulations at 21 CFR part 1, subpart H. During the most recent inspection, you were advised of this requirement. Our records indicate that, to date, your facility has not been registered with FDA. Failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)).
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.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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. We may place the foods you import 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 these violations. You should include in your response documentation and information that will 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 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: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831.
If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 673621 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports Acting PDD
WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-india-bazar-inc-677343-04012024
New India Bazar, Inc.
MARCS-CMS 677343 — APRIL 01, 2024
Recipient:
Hamant K. Sharda
President
New India Bazar, Inc.
885 Yosemite Way
Milpitas, CA 95035
United States
hamantsharda@newindiabazar.com
vickysangar@newindiabazar.com
Issuing Office:
Division of West Coast Imports
United States
April 1, 2024
C/c Vicky R. Sangar, Director
Re: CMS 677343
Dear Mr. Sharda:
On November 14, November 15, December 4, December 18, and December 21, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of New India Bazar, Inc., located at 885 Yosemite Way, Milpitas, CA 95035. 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-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
Our inspection was initiated in response to the recent recall event associated with MAGGI Noodles imported by you from one of your foreign suppliers. Specifically, you were notified by the FDA that the 280g and 560g product labels imported from your foreign supplier, (b)(4), located in (b)(4) and (b)(4), were examined and found to contain undeclared allergens. The label listed “hydrolyzed groundnut protein” as an ingredient without clarifying that this referred to peanuts, and without declaring peanuts on the product label. In response to these findings, you conducted a voluntary recall of the imported MAGGI Noodles on December 04, 2023.
During the FSVP 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 FSVP inspection, our investigators provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated January 15, 2024. Your response included brief statements after each observation regarding your contact with, or intent to obtain documentation from, your suppliers so as to correct the deficiencies in the coming weeks. We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.
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 the foods from the foreign suppliers indicated in the attached FSVP011 list, as well as the following foods:
Masala Munch Snack, imported from (b)(4), located in India
Chat Papri, imported from (b)(4), located in India
Gujarati Chavana (snack), imported from (b)(4), located in India
2. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the products you import. Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. During the inspection, you told our investigators that for the foods you import, you evaluate your foreign suppliers solely by reviewing the foreign supplier’s regulatory history on FDA’s Data Dashboard. This information is relevant in reviewing foreign supplier compliance with FDA regulations under 21 CFR 1.505(a)(1)(iii)(B), but it does not provide all of the information that must be considered under 21 CFR 1.505(a) in evaluating a foreign supplier’s performance and the risk posed by a food.
In addition, for your Gajjak Moongfali Snack (peanut brittle) imported from (b)(4) (exporter), your evaluation did not consider the foreign suppliers of the foods. Per 21 CFR 1.500, foreign supplier means, for an article of food, 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, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. You reviewed (b)(4) regulatory history on FDA’s Data Dashboard, but did not review any information regarding the foreign suppliers that manufactured the food.
3. You did not conduct a written hazard analysis for each type of food you import to determine whether there are any foreseeable hazards requiring a control, as required by 21 CFR 1.504. Specifically, your hazard analyses for the foods you imported from (b)(4) (exporter), (b)(4), namely, NOODLES - MAGGI 280g and 560g from foreign suppler (b)(4) located in (b)(4); Gujarati Chavana (snack) from foreign suppler (b)(4); and GAJJAK MOONGFALI SNACK (peanut brittle) and Chat Papri from unknown foreign suppliers imported by (b)(4), failed to identify allergens as a chemical hazard. See 21 CFR 1.504(b)(ii).
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506(e) for the products you import. 21 CFR 1.506(e) provides that you must conduct (and document) or obtain documentation of one or more of the following supplier verification activities for each foreign supplier before importing the food and periodically thereafter: (i) onsite audit of the foreign supplier; (ii) sampling and testing of the food; (iii) review of the foreign supplier’s relevant food safety records; or (iv) other appropriate activity. See 21 CFR 1.506(e)(i)-(iv). During the inspection, you told our investigators that your firm’s verification activities for your foreign suppliers consist solely of reviewing the Foreign Supplier’s regulatory history on FDA’s Data Dashboard. This information is relevant in reviewing foreign supplier compliance with FDA regulations under 21 CFR 1.505(a)(1)(iii)(B), but it does not provide all the information that must be considered under 21 CFR 1.505(e)(iii) and (iv) in reviewing a foreign supplier’s relevant food safety records and other appropriate activities. For your foods imported from (b)(4) (exporter) you also provided a “Site Audit report”, conducted by a third-party firm, (b)(4). However, the verification activities conducted for the foods you import from (b)(4) (exporter) did not consider the foreign suppliers of the foods you import.
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 food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States from the identified foreign supplier 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, 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 677343 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
Hamant K. Sharda
President
New India Bazar, Inc.
885 Yosemite Way
Milpitas, CA 95035
United States
hamantsharda@newindiabazar.com
vickysangar@newindiabazar.com
Issuing Office:
Division of West Coast Imports
United States
April 1, 2024
C/c Vicky R. Sangar, Director
Re: CMS 677343
Dear Mr. Sharda:
On November 14, November 15, December 4, December 18, and December 21, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of New India Bazar, Inc., located at 885 Yosemite Way, Milpitas, CA 95035. 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-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
Our inspection was initiated in response to the recent recall event associated with MAGGI Noodles imported by you from one of your foreign suppliers. Specifically, you were notified by the FDA that the 280g and 560g product labels imported from your foreign supplier, (b)(4), located in (b)(4) and (b)(4), were examined and found to contain undeclared allergens. The label listed “hydrolyzed groundnut protein” as an ingredient without clarifying that this referred to peanuts, and without declaring peanuts on the product label. In response to these findings, you conducted a voluntary recall of the imported MAGGI Noodles on December 04, 2023.
During the FSVP 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 FSVP inspection, our investigators provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated January 15, 2024. Your response included brief statements after each observation regarding your contact with, or intent to obtain documentation from, your suppliers so as to correct the deficiencies in the coming weeks. We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.
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 the foods from the foreign suppliers indicated in the attached FSVP011 list, as well as the following foods:
Masala Munch Snack, imported from (b)(4), located in India
Chat Papri, imported from (b)(4), located in India
Gujarati Chavana (snack), imported from (b)(4), located in India
2. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the products you import. Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. During the inspection, you told our investigators that for the foods you import, you evaluate your foreign suppliers solely by reviewing the foreign supplier’s regulatory history on FDA’s Data Dashboard. This information is relevant in reviewing foreign supplier compliance with FDA regulations under 21 CFR 1.505(a)(1)(iii)(B), but it does not provide all of the information that must be considered under 21 CFR 1.505(a) in evaluating a foreign supplier’s performance and the risk posed by a food.
In addition, for your Gajjak Moongfali Snack (peanut brittle) imported from (b)(4) (exporter), your evaluation did not consider the foreign suppliers of the foods. Per 21 CFR 1.500, foreign supplier means, for an article of food, 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, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. You reviewed (b)(4) regulatory history on FDA’s Data Dashboard, but did not review any information regarding the foreign suppliers that manufactured the food.
3. You did not conduct a written hazard analysis for each type of food you import to determine whether there are any foreseeable hazards requiring a control, as required by 21 CFR 1.504. Specifically, your hazard analyses for the foods you imported from (b)(4) (exporter), (b)(4), namely, NOODLES - MAGGI 280g and 560g from foreign suppler (b)(4) located in (b)(4); Gujarati Chavana (snack) from foreign suppler (b)(4); and GAJJAK MOONGFALI SNACK (peanut brittle) and Chat Papri from unknown foreign suppliers imported by (b)(4), failed to identify allergens as a chemical hazard. See 21 CFR 1.504(b)(ii).
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506(e) for the products you import. 21 CFR 1.506(e) provides that you must conduct (and document) or obtain documentation of one or more of the following supplier verification activities for each foreign supplier before importing the food and periodically thereafter: (i) onsite audit of the foreign supplier; (ii) sampling and testing of the food; (iii) review of the foreign supplier’s relevant food safety records; or (iv) other appropriate activity. See 21 CFR 1.506(e)(i)-(iv). During the inspection, you told our investigators that your firm’s verification activities for your foreign suppliers consist solely of reviewing the Foreign Supplier’s regulatory history on FDA’s Data Dashboard. This information is relevant in reviewing foreign supplier compliance with FDA regulations under 21 CFR 1.505(a)(1)(iii)(B), but it does not provide all the information that must be considered under 21 CFR 1.505(e)(iii) and (iv) in reviewing a foreign supplier’s relevant food safety records and other appropriate activities. For your foods imported from (b)(4) (exporter) you also provided a “Site Audit report”, conducted by a third-party firm, (b)(4). However, the verification activities conducted for the foods you import from (b)(4) (exporter) did not consider the foreign suppliers of the foods you import.
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 food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States from the identified foreign supplier 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, 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 677343 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
No comments:
Post a Comment