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.
Green City Distribution
Dearborn, MI
An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 30 warning letter, the FDA described a March 25-29, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Green City Distribution in Dearborn, MI.
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, they did not develop, maintain, and follow an FSVP for any of the foods they import including each of the following food products:
- broad beans manufactured by (redacted)
- broad beans manufactured by (redacted)
- kidney beans manufactured by (redacted)
- coconut fudge manufactured by (redacted
For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled, the firm must verify and document that the food was produced in accordance with 21 CFR part 113, as required. The firm did not verify and document that their products – canned broad beans and kidney beans – low-acid canned foods, were produced in accordance with 21 CFR part 113 , as required.
The full warning letter can be viewed here.
2m Associates Inc.
New York City
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 20 warning letter, the FDA described a Feb. 1 through March 3, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of 2m Associates Inc. in New York City.
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, they did not develop, maintain, and follow an FSVP for any of the foods their import including each of the following food products:
- (redacted) broken rice imported from (redacted), located in (redacted).
- (redacted) rice imported from (redacted), located in (redacted).
The full warning letter can be viewed here.
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