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.
Fitsum Ghebremichael Amare
Oakland, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 20 warning letter, the FDA described inspections on May 13, June 2 and June 24, 2021, for violations of the Foreign Supplier Verification Program (FSVP) at Fitsum Ghrebremichael Amare in Oakland, CA.
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:
- Teff Grain imported from (redacted) located in (redacted)
- Teff Grain imported from (redacted) located in (redacted)
- Teff Grain and Brown Teff Grain imported from (redacted) located in (redacted)
- Brown Teff Grain imported from (redacted) located in (redacted)
The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
The full warning letter can be viewed here.
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