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3/29/2023

WARNING LETTER

Re: CMS # 649717

Dear Mr. Yue S. Liang:

On November 21, 2022 to December 12, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Five Star Trading IL, Inc. located at 6064 N Sauganash Ave., Chicago, IL 60646. 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/GuidanceRegulation/FSMA/ucm361902.htm.

During the 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 investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your email responses dated December 27, 2022, and we address your responses below.

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, maintain, and follow an FSVP for the foods from the foreign suppliers indicated in the attached list. Your email responses dated December 27, 2022 did not provide any FSVP documents.

2. You did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). Specifically, you did not conduct and document (or obtain documentation of) one or more such supplier verification activities for your foreign suppliers (b)(4) and (b)(4), both located in (b)(4), before importing dried black peppercorn and dried black fungus, respectively, and periodically thereafter. During the inspection, you provided your FSVP for dried black peppercorn, which lists the verification activities that are to be conducted, including review of the following documents: Food Safety Plan or HACCP plan ((b)(4) or upon reassessment); GMP program, SSOP, and third-party audits ((b)(4)); certificate of analysis (microbiological and chemical) ((b)(4)); and finished product testing (biological, chemical, physical) ((b)(4)). However, while you provided records of finished product testing for dried black peppercorn, you did not document that you conducted any of the other listed verification activities. In your FSVP for dried black fungus, you documented that you determined verification activities were a review of the following documents: HACCP plan ((b)(4) or upon reassessment); GMP program, SSOP, and third-party audits ((b)(4)); certificate of analysis ((b)(4)), and finished product testing (biological, chemical, physical) ((b)(4)). However, in your email responses dated December 27, 2022, your documentation of verification activities for dried black fungus included only copies of the foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures.

3. You did not promptly document your review and assessment of the results of a verification activity that was conducted by another entity in accordance with 21 CFR 1.506(e)(3). Specifically, you did not have documentation that you reviewed and assessed the food product testing laboratory report for your dried black peppercorn imported from (b)(4), and your foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures for your dried black fungus imported from (b)(4).

4. You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English, as required by 21 CFR 1.510(b)(1). However, you did not provide an English translation of the following FSVP document after the investigator’s request of the referenced document in English: finished product laboratory report for dried black peppercorn imported from (b)(4). To date you have still not provided the requested translation of this document.

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 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 corrective actions (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 corrective actions 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: Christinaé Hudson, Compliance Officer, Division of Northern Border Imports, 550 West Jackson Blvd., Chicago, IL 60661. If you have any questions regarding this letter, you may contact Christinaé Hudson via email at [email protected]. Please reference CMS # 649717 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/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports