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.
7333 LLC
Lakewood, WA
An import company in Washington is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 13, 2022, warning letter, the FDA described a Dec. 8 through Dec. 20, 2021, Foreign Supplier Verification Program (FSVP) inspection of 7333 LLC in Lakewood, WA.
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:
- (Redacted) Scorched Barley imported from (redacted)
- Frozen Dumpling imported from (redacted)
- Macaroni imported from (redacted)
- Rice Noodle Soup imported from (redacted)
The full warning letter can be viewed here.
Alymar LLC
Houston, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 12, 2022, warning letter, the FDA described a Jan. 3-11, 2021, Foreign Supplier Verification Program (FSVP) inspection of Alymar LLC in Houston, TX.
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:
- Cola soft drinks imported from (redacted), located in (redacted)
- Potato chips imported from (redacted), located in (redacted)
- Corn chips imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
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