Editor’s note: 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.
Companies likely will be taking FDA warnings a bit more seriously now that the FDA, for the first time, has 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 the agency sent a warning letter to the firm and more than nine years after gaining the power to do so.
DN Imports Inc., Missouri City, 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 Sept. 4 warning letter, the FDA described May 15 and June 11 Foreign Supplier Verification Program (FSVP) inspections at DN Imports, Inc.
The FDA’s inspections 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:
- Mushroom soup powder imported from (redacted)., located in (redacted);
- Seasoning sauce with garlic and chili imported from (redacted)., located in (redacted).
- Roasted corn imported from (redacted)., located in (redacted).
The full warning letter can be viewed here.
Curious about why there are redactions by the FDA? We took a look at why in this recent opinion piece.
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