Companies in Texas, Washington receive FDA warning letters for import violations

As a part of its enforcement actions, the Meals and Drug Administration sends warning letters to entities below its jurisdiction. Some letters will not be posted for public view till weeks or months after they’re despatched. Enterprise homeowners have 15 days to answer FDA warning letters. Warning letters usually will not be issued till an organization has been given months to years to appropriate issues.

7333 LLC
Lakewood, WA

An import firm in Washington is on discover from the FDA for not having FSVPs for a lot of imported meals merchandise.

In an April 13, 2022, warning letter, the FDA described a Dec. 8 by means of Dec. 20, 2021, Overseas Provider Verification Program (FSVP) inspection of 7333 LLC in Lakewood, WA.

The FDA’s inspection revealed that the agency was not in compliance with FSVP laws and resulted within the issuance of an FDA Type 483a. The numerous violations are as follows:

The agency didn’t develop, keep, and comply with an FSVP. Particularly, they didn’t develop an FSVP for every of the next meals:

• (Redacted) Scorched Barley imported from (redacted)
• Frozen Dumpling imported from (redacted)
• Macaroni imported from (redacted)
• Rice Noodle Soup imported from (redacted)

The total warning letter may be considered right here.

Alymar LLC
Houston, TX

An import firm in Texas is on discover from the FDA for not having FSVPs for a lot of imported meals merchandise.

In an April 12, 2022, warning letter, the FDA described a Jan. 3-11, 2021, Overseas Provider Verification Program (FSVP) inspection of Alymar LLC in Houston, TX.

The FDA’s inspection revealed that the agency was not in compliance with FSVP laws and resulted within the issuance of an FDA Type 483a. The numerous violations are as follows:

The agency didn’t develop, keep, and comply with an FSVP. Particularly, they didn’t develop an FSVP for every of the next meals:

• Cola mushy drinks imported from (redacted), situated in (redacted)
• Potato chips imported from (redacted), situated in (redacted)
• Corn chips imported from (redacted), situated in (redacted)

The total warning letter may be considered right here.

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