As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Alma Reserve
Brooklyn, NY
An import company in Brooklyn Is on notice from the FDA for not having certain import verifications for a number of imported food products.
In a Jan. 19 warning letter, the FDA described an Oct. 8 to Nov. 9 2020, remote Foreign Supplier Verification Program (FSVP) inspection for Alma Reserve.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Fudge candy
- Cookies
- Rice cakes
The three products were all imported from the same (redacted) foreign supplier.
The full warning letter can be viewed here.
Thai Kee Trading Co.
San Jose, CA
An import company in California Is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Jan. 8 warning letter, the FDA described an Aug. 26 and 28, 2020, Foreign Supplier Verification Program (FSVP) inspection at Thai Kee Trading Co.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
- The firm did not meet the requirements to conduct a hazard analysis for the products they import. They may meet the requirement by reviewing and assessing their foreign supplier’s hazard analysis and documenting their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During FDA inspection, the firm provided copies of their foreign supplier’s hazard analyses for Tusino curing powder and canned mushroom vegetarian broth imported from (redacted), as well as this supplier’s hazard analyses for three other products that they import from them. As far as they rely on these hazard analyses to meet their obligations under the FSVP regulation, they did not document their review and assessment of their foreign supplier’s hazard analysis. The firm also did not provide a written hazard analysis for their Thai jasmine rice imported from (redacted).
- The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food and document their use of these procedures. During FDA inspection they provided their 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 their Thai jasmine rice imported from (redacted); Tusino curing powder and canned mushroom vegetarian broth imported from (redacted), they did not have any such supplier evaluation information. The firm also did not document their evaluation and approval of their foreign suppliers.
- The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. They must establish and follow adequate written procedures for ensuring that they conduct appropriate foreign supplier verification activities with respect to the foods they import. The document they provided during the FDA’s recent inspection and at the close of the inspection in 2017 titled, “Flow chart FOREIGN SUPPLIER VERIFICATION PROGRAM” includes mention of relevant foreign supplier verification activities, including (redacted) on-site audits and reviewing the supplier’s relevant food safety records. However, the firm did not document that they 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 (redacted); Tusino curing powder and mushroom vegetarian broth imported from (redacted).
- 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, they must verify and document that the food was produced. For their canned mushroom vegetarian broth imported from (redacted), they did not verify and document that the food was produced in accordance with 21 CFR part 113.
The full warning letter can be viewed here.
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