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WARNING LETTER

WCS Trading, Inc. MARCS-CMS 610186 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
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

 
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