Fitsum Ghebremichael Amare

Warning LetterOpen

Fitsum Ghrebremichael Amare Owner Fitsum Ghebremichael Amare 978 81st Ave Oakland , CA 94621-2512 United StatesFEI 3012504269Issued Oct 20, 2021Division of West Coast Imports

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Violations3

Issue DateOct 20, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: Fitsum Ghebremichael Amare
Location: Fitsum Ghrebremichael Amare Owner Fitsum Ghebremichael Amare 978 81st Ave Oakland , CA 94621-2512 United States
FEI Number: 3012504269
Country: United States
Issue Date: October 20, 2021
Issuing Office: Division of West Coast Imports
Product Type: Other
Status: Open

Summary

Fitsum Ghebremichael Amare, a food importer in Oakland, CA, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by federal law for imported foods including Teff Grain and Brown Teff Grain from foreign suppliers. The FDA conducted multiple inspections between June 2019 and June 2021 and found the company had not established any FSVP documentation for the foods it imported, representing a significant violation of 21 CFR part 1, subpart L. The company did not respond to the FDA's Form 483a observations issued on June 24, 2021, prior to the warning letter being sent in October 2021.

Fitsum Ghebremichael Amare FDA Warning Letter, October 20, 2021