FDA warns Oakland meals firm of violations of import laws

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are only released for public inspection weeks or months after they have been sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often only issued after a company has been given months or years to resolve problems. The FDA often edits parts of warning letters that are published to the public.

Fitsum Ghebremichael Amare
Oakland, California

An import company in California is notified by the FDA because it does not have FSVPs for a number of imported foods.

In an October 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, California.

The FDA’s inspection found the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

In particular, the company has not developed a FSVP for any of the foods it imports, including the following foods:

  • Teff imported from grain (blackened) located in (blackened)
  • Teff imported from grain (blackened) located in (blackened)
  • Teff Grain and Brown Teff Grain imported from (blackened) located in (blackened)
  • Brown teff grain imported from (blackened) located in (blackened)

The FSVP requires importers that their overseas suppliers of food for human and animal consumption meet the applicable FDA safety standards.

The full warning letter can be viewed here.

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