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.
IDC USA INC
Brooklyn, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 21 warning letter, the FDA described a Dec. 3, 2020 through Feb. 24, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of IDC USA Inc. in Brooklyn, NY.
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, maintain, and follow an FSVP for any of the food products they import, including the following foods:
- The firm did not develop, maintain, and follow an FSVP as required. Specifically, the firm did not develop an FSVP for their dried longan and dried (redacted) dates imported from (redacted) located in (redacted).
- The firm did not conduct a written hazard analysis for their dried fungus imported from (redacted) located in (redacted) to determine whether there are any hazards requiring a control. The FDA notes that they may meet their requirement to conduct a hazard analysis, by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of that hazard analysis. The FSVP regulation also generally requires that they evaluate their foreign supplier’s performance and conduct foreign supplier verification activities, among other requirements. With respect to their evaluation of a foreign supplier’s performance, they may rely on another entity’s evaluation, but that entity may not be the foreign supplier themselves, and they must document their review and assessment of the evaluation. In addition, the firm provided private laboratory analysis for shipments of dried (redacted) dates imported from (redacted) and dried longan imported from (redacted). While sampling and testing of a food may be an appropriate supplier verification activity, the testing should be specific to the hazards being controlled, among other requirements.
The full warning letter can be viewed here.
STB Quarters, LLC
Chicago, IL
An import company in Chicago is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 8 warning letter, the FDA described a Feb. 1 through March 10, 2020, remote Foreign Supplier Verification Program (FSVP) inspection of STB Quarters, LLC in Chicago, IL.
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 as required. Specifically, the firm did not develop an FSVP for any of the foods they import, including the following foods:
- Tahini/Sesame Paste manufactured by (redacted); and
- Sesame Seeds manufactured by (redacted)
On Feb. 25, 2021, the firm emailed FDA investigators a variety of documents for their tahini/sesame paste and sesame seed products, including certificates of analysis, ISO certificates, a Kosher certificate, and a HACCP certificate. However, the documents that are relevant to an FSVP are incomplete, and they did not provide a record of the firm’s review of the relevant documents or explain how they would apply to their FSVP program. Thus, these documents do not constitute an FSVP as required.
The full warning letter can be viewed here.
International General Trading Corp.
New York, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 17 warning letter, the FDA described a March 16 to April 15, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of International General Trading Corp. in New York, NY.
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 as required. Specifically, the firm did not develop, maintain, and follow an FSVP for (redacted) Wafers and (redacted) Hazelnut Spread imported from (redacted); and (redacted) Noodles imported from (redacted).
The full warning letter can be viewed here.
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