As a part of its enforcement actions, the Meals and Drug Management sends caution letters to entities below its jurisdiction. Some letters aren’t posted for public view till weeks or months after they’re despatched. Industry homeowners have 15 days to answer FDA caution letters. Caution letters continuously aren’t issued till an organization has been given months to years to right kind issues.
7333 LLC
Lakewood, WA
An import corporate in Washington is on realize from the FDA for now not having FSVPs for quite a lot of imported meals merchandise.
In an April 13, 2022, caution letter, the FDA described a Dec. 8 via Dec. 20, 2021, Overseas Provider Verification Program (FSVP) inspection of 7333 LLC in Lakewood, WA.
The FDA’s inspection published that the company was once now not in compliance with FSVP rules and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t broaden, deal with, and practice an FSVP. Particularly, they didn’t broaden 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 whole caution letter may also be considered right here.
Alymar LLC
Houston, TX
An import corporate in Texas is on realize from the FDA for now not having FSVPs for quite a lot of imported meals merchandise.
In an April 12, 2022, caution 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 published that the company was once now not in compliance with FSVP rules and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t broaden, deal with, and practice an FSVP. Particularly, they didn’t broaden an FSVP for every of the next meals:
- Cola comfortable beverages imported from (redacted), positioned in (redacted)
- Potato chips imported from (redacted), positioned in (redacted)
- Corn chips imported from (redacted), positioned in (redacted)
The whole caution letter may also be considered right here.
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