- E & H Distributors LLC of , San Diego, CA did not have FSVPs for soft tamarind flavored candy from one supplier and candy imported from another foreign supplier.
- World Candy Store LLC, of Brownsville, Texas 78521. did not have FSVPs for these products, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4).
- WCS Trading Inc, of Los Angeles, CA 90032 did not complete a review of the supplier's hazard analysis and did not perform verification activities for dried crushed chili, dried black fungus and dried mushrooms
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020
Recipient:
Jesus Adrian Rodriguez
Import and Export Manager
E&H Distributors LLC
4630 Border Village Rd Ste 4113
San Ysidro, CA 92173-3121
United States
Issuing Office:
Division of Southwest Imports
United States
November 04, 2020
WARNING LETTER
Re: CMS # 610883
Dear Mr. Rodriguez:
On May 5, 2020 to August 4, 2020, the Food and Drug Administration (FDA) conducted a remote follow-up Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm E & H Distributors LLC, located at 6774 Calle De Linea, Suite 104/105, San Diego, CA 92154. We also conducted an initial inspection on September 12, 2017. 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/GuidanceRegulation/FSMA/ucm361902.htm
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your (b)(4) soft tamarind flavored candy imported from your foreign supplier (b)(4) and (b)(4) candy imported from your foreign supplier (b)(4). You did not have FSVPs for these products or any food products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 12, 2017 and the follow-up inspection on August 4, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a from the most recent follow-up inspection.
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, your firm did not develop an FSVP for each of the following foods:
• (b)(4) soft tamarind flavored candy imported from (b)(4)
• (b)(4) candy imported from (b)(4)
You initially told our investigator on May 5, 2020 that you did not have any FSVPs for any food products that you import and that you would later send them electronically. On May 15, 2020, you emailed our investigator a form that you purported to be your FSVP. However, the form is simply a document titled “Determining the FSVP Importer” that is not specific to your firm, your products, or your foreign suppliers. This document does not cover, even in part, an FSVP plan as required by 21 CFR 1.502(a) such that it provides adequate assurances that your foreign suppliers are producing each food you import in compliance with processes and procedures that provide at least the same level of public health protection as those in the FD&C Act.
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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. We may place the foods you import on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at https://www.accessdata.fda.gov/cms_ia/importalert_1160.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.
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 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 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: Joseph Brady, Compliance Officer, Division of Southwest Imports, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154.
If you have any questions regarding this letter, you may contact CO Brady via email at joseph.brady@fda.hhs.gov. Please reference CMS # 610883 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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/world-candy-store-llc-611073-11032020
WARNING LETTER
World Candy Store LLC
MARCS-CMS 611073 — November 03, 2020
Recipient:
World Candy Store LLC
United States
Issuing Office:
Division of Southwest Imports
United States
November 3, 2020
WARNING LETTER
Re: CMS # 611073
Dear Mr. Ramirez,
From September 3 to 11, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of World Candy Store LLC, located at 1921 Anei Circle, Brownsville, Texas 78521. We also conducted an inspection on August 17, 2017. 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 food products you import including, but not limited to, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection in August 2017 and the follow-up inspection in September 2020, our investigator provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response via email dated October 2, 2020, in which you provided a document titled, “FSVP Implementation Plan.” This document stated you have hired a qualified individual, Mr. (b)(6), (b)(4), to “create and develop the new FSVP” for you. This document also provides target dates for additional actions, including to “[c]reate new procedures to integrate all the aspects of the FSVP.” We are unable to evaluate the adequacy of this response because you did not provide any documents or records related to your FSVP program. Additionally, we note that at the conclusion of the initial FSVP inspection in August 2017, our investigator provided you with a Form FDA 483a, to which you responded that you “had hired a professional advisor (Mr. (b)(6), (b)(4)) to work full time in our company commencing last Monday August 28, 2017 and its only task will be the implementation of FSVP inside our company.” However, to date, you still have not provided FSVPs for any of the food products you import.
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 food products you import, including:
• Ricolino Huevito Pinto imported from (b)(4)
• Ricolino Huevito imported from (b)(4)
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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 products you import. We may place the food products you import on detention without physical examination (DWPE) when you import the products. 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.
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 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 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: Attention: Kendra J. Vieira, Compliance Officer, 2320 Paseo de las Americas, Suite 208, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Kendra J Vieira via email at Kendra.Vieira@fda.hhs.gov.
Please reference CMS # 611073 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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wcs-trading-inc-610186-10082020
WARNING LETTER
WCS Trading, Inc.
MARCS-CMS 610186 — October 08, 2020
Recipient:
Mr. Meng Hua Wang
WCS Trading, Inc.
2430 Mariondale Ave.
Los Angeles, CA 90032
United States
Issuing Office:
Division of West Coast Imports
United States
Warning Letter
October 8, 2020
Re: CMS # 610186
Dear Mr. Meng Hua Wang:
On May 14, 2020 to May 26, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for WCS Trading Inc, located at 2430 Mariondale Ave., Los Angeles, CA 90032. We also conducted an inspection on September 12, 2018. 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, dried crushed chili you import from (b)(4) and dried black fungus and dried mushrooms you import from (b)(4) both located in (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 FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email responses dated June 8, 2020, and letter dated May 16, 2020 authorizing your consultant (b)(4) to represent WCS Trading. You provided three sets of documents in your June 8, 2020 emails. The documents included Hazard Analysis and Critical Control Point (HACCP) plans for your dried mushrooms, black fungus, and dried chili product from your foreign suppliers. Your emails also included Certificates of Analysis for Vendors of WCS Trading, (b)(4) test reports, and Vendor Assessment Forms related to the products you import. You also provided your firm’s Standard Operating Procedures (SOP) for personnel and training; customer complaints; corrective and preventive action; recall procedure; lot code and coding standard; nonconformance report form; inventory control, handling, distribution procedure; procedures for document control and change on Good Manufacturing Practice (GMP) documents; and purchasing procedures.
Our review of your response finds that you have not addressed all the violations related to the food products you import, as further described in this letter.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirement to review another entity’s hazard analysis as required by section 21 CFR 1.504(d) to determine whether there are any hazards requiring a control. Specifically, on June 8, 2020, your consultant submitted HACCP plans for your dried black fungus and dried mushrooms imported from (b)(4); and dried chili products (crushed, whole, and ring) imported from (b)(4). You did not document your review and assessment of the hazard analyses conducted by your consultant, as required by 21 CFR 1.504(d).
2. You did not meet the requirement to evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505 for the products you import. Specifically, for your dried black fungus and dried mushrooms imported from (b)(4) located (b)(4), you provided your “procedures for evaluating vendors” and a corresponding “Vendor Assessment Form” for a different supplier, (b)(4). However, you did not provide documentation of your evaluation of your supplier (b)(4) in accordance with 21 CFR 1.505(a)(2) or your approval of this supplier in accordance with 21 CFR 1.505(b).
3. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import, including establishing written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b) and documenting your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d). Specifically, you did not document your determination or performance of appropriate supplier verification activities for your crushed chili products imported from (b)(4) located in (b)(4) or your dried mushrooms and dried black fungus imported from (b)(4) located in (b)(4). We acknowledge you obtained third party reports for filth analysis for certain shipments of dried mushrooms and dried black fungus; however, you did not first determine and document that these verification activities will provide adequate assurances that the food you obtain from your foreign supplier is produced in accordance with 21 CFR 1.506(c), i.e., that the hazards requiring a control in the food you import have been significantly minimized or prevented.
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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 dried crushed chili imported from (b)(4), and dried black fungus and dried mushrooms imported from (b)(4), both located in (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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.
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 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 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: Steven L. Robbs, 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 Steven Robbs via email at steven.robbs@fda.hhs.gov.
Please reference CMS # 610186 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
Dear Mr. Meng Hua Wang:
On May 14, 2020 to May 26, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for WCS Trading Inc, located at 2430 Mariondale Ave., Los Angeles, CA 90032. We also conducted an inspection on September 12, 2018. 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, dried crushed chili you import from (b)(4) and dried black fungus and dried mushrooms you import from (b)(4) both located in (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 FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email responses dated June 8, 2020, and letter dated May 16, 2020 authorizing your consultant (b)(4) to represent WCS Trading. You provided three sets of documents in your June 8, 2020 emails. The documents included Hazard Analysis and Critical Control Point (HACCP) plans for your dried mushrooms, black fungus, and dried chili product from your foreign suppliers. Your emails also included Certificates of Analysis for Vendors of WCS Trading, (b)(4) test reports, and Vendor Assessment Forms related to the products you import. You also provided your firm’s Standard Operating Procedures (SOP) for personnel and training; customer complaints; corrective and preventive action; recall procedure; lot code and coding standard; nonconformance report form; inventory control, handling, distribution procedure; procedures for document control and change on Good Manufacturing Practice (GMP) documents; and purchasing procedures.
Our review of your response finds that you have not addressed all the violations related to the food products you import, as further described in this letter.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirement to review another entity’s hazard analysis as required by section 21 CFR 1.504(d) to determine whether there are any hazards requiring a control. Specifically, on June 8, 2020, your consultant submitted HACCP plans for your dried black fungus and dried mushrooms imported from (b)(4); and dried chili products (crushed, whole, and ring) imported from (b)(4). You did not document your review and assessment of the hazard analyses conducted by your consultant, as required by 21 CFR 1.504(d).
2. You did not meet the requirement to evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505 for the products you import. Specifically, for your dried black fungus and dried mushrooms imported from (b)(4) located (b)(4), you provided your “procedures for evaluating vendors” and a corresponding “Vendor Assessment Form” for a different supplier, (b)(4). However, you did not provide documentation of your evaluation of your supplier (b)(4) in accordance with 21 CFR 1.505(a)(2) or your approval of this supplier in accordance with 21 CFR 1.505(b).
3. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import, including establishing written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b) and documenting your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d). Specifically, you did not document your determination or performance of appropriate supplier verification activities for your crushed chili products imported from (b)(4) located in (b)(4) or your dried mushrooms and dried black fungus imported from (b)(4) located in (b)(4). We acknowledge you obtained third party reports for filth analysis for certain shipments of dried mushrooms and dried black fungus; however, you did not first determine and document that these verification activities will provide adequate assurances that the food you obtain from your foreign supplier is produced in accordance with 21 CFR 1.506(c), i.e., that the hazards requiring a control in the food you import have been significantly minimized or prevented.
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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 dried crushed chili imported from (b)(4), and dried black fungus and dried mushrooms imported from (b)(4), both located in (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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.
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 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 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: Steven L. Robbs, 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 Steven Robbs via email at steven.robbs@fda.hhs.gov.
Please reference CMS # 610186 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
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