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.
FMT Services, LLC
Grand Prairie, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 29 warning letter, the FDA described a March 22, 2021, Foreign Supplier Verification Program (FSVP) inspection of FMT Services, LLC in Grand Prairie, TX.
“At the conclusion of the initial FSVP inspection on Sept. 11, 2018, and the follow-up inspection on March 22, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. As of the date of this letter, we have not received your response to either Form FDA 483a,” according to the warning letter.
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.
Specifically, the firm did not develop an FSVP for any of the foods they import, including the following foods:
- Corn flour and quicklime imported from (redacted)
- Quicklime imported from (redacted)
The full warning letter can be viewed here.
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