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.

Last week companies realized the FDA’s warning letters are no empty threats.

On Sept. 15, the FDA for the first time issued a consent decree of permanent injunction against a firm for violating public safety standards under the Produce Safety Rule. This injunction comes two years after sending a warning letter to the firm and more than nine years after gaining the power to do so.

GMS International Foods Inc., Torrence, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 27 warning letter, the FDA described an April 15-17 and 19-21, 2020, Foreign Supplier Verification Program (FSVP) inspection at GMS International Foods Inc.

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:

  • Pran Puffed Rice imported from (redacted), located in (redacted)
  • Pran Kalizera Rice imported from (redacted), located in (redacted)
  • Pran Flattened Rice imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

Curious about why there are redactions in FDA warning letters? We recently took a look at this in an opinion piece.

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