- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameLawrence T. Huang
- Thai Kee Trading Co
660 N. King Rd.
San Jose, CA 95133-1715
- Issuing Office:
- Division of West Coast Imports
January 8, 2021
Re: CMS # 610899
Dear Mr. Lawrence T. Huang:
On August 26 and August 28, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Thai Kee Trading Co, located at 660 N. King Rd., San Jose, CA 91533-1715. We also conducted an inspection on September 28, 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 under 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVPs for your Thai Jasmine rice imported from (b)(4) and Tusino curing powder and canned mushroom vegetarian broth imported from (b)(4). Additionally, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for other foods you import, in that 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 the both the most recent inspection on August 28, 2020 and the initial inspection on September 28, 2017, our investigator provided you with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirements to conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. You may meet the requirement by reviewing and assessing your foreign supplier’s hazard analysis and documenting your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During our inspection, you provided copies of your foreign supplier’s hazard analyses for Tusino curing powder and canned mushroom vegetarian broth imported from (b)(4), as well as this supplier’s hazard analyses for three other products that you import from them. As far as you rely on these hazard analyses to meet your obligations under the FSVP regulation, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). You also did not provide a written hazard analysis for your Thai Jasmine rice imported from (b)(4).
2. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 21 CFR 1.506(a)(1). During our inspection you provided your document titled, “Flow chart FOREIGN SUPPLIER VERIFICATION PROGRAM” which includes a list of activities such as obtaining a HACCP plan and checking the supplier’s record online for recalls, refusals, and import alerts. However, for your Thai Jasmine rice imported from (b)(4); Tusino curing powder and canned mushroom vegetarian broth imported from (b)(4), you did not have any such supplier evaluation information. You also did not document your evaluation and approval of your foreign suppliers, as required by 21 CFR 1.505(a) and 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. You must establish and follow adequate written procedures for ensuring that you conduct appropriate foreign supplier verification activities with respect to the foods you import as required by 21 CFR 1.506(b). The document you provided during our recent inspection and at the close of our inspection in 2017 titled, “Flow chart FOREIGN SUPPLIER VERIFICATION PROGRAM” includes mention of relevant foreign supplier verification activities, including (b)(4) onsite audits and reviewing the supplier’s relevant food safety records. However, you did not document that you establish and follow procedures for determining the appropriate verification activity or conduct and document or obtain documentation of one or more of the supplier verification activities for Thai Jasmine rice imported from (b)(4); Tusino curing powder and mushroom vegetarian broth imported from (b)(4), as required by 21 CFR 1.506(b) and 1.506(e).
4. In addition, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113. For your canned mushroom vegetarian broth imported from (b)(4), you did not verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
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.
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.
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 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: Debbie Giang, 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 Debbie Giang via phone at (562) 256-9235 or via email at firstname.lastname@example.org. Please reference CMS #610899 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Acting Program Division Director
Division of West Coast Imports