Myllan-ORA ehf

Warning LetterClosed

Mr. Hermann Stefansson CEO Myllan-ORA ehf Vesturvor 12 200 Kopavogur IcelandFEI 3001017171Issued Aug 30, 2022Center for Food Safety and Applied Nutrition (CFSAN)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3001017171.

Letter Details

Firm: Myllan-ORA ehf
Location: Mr. Hermann Stefansson CEO Myllan-ORA ehf Vesturvor 12 200 Kopavogur Iceland
FEI Number: 3001017171
Country: Iceland
Issue Date: August 30, 2022
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Food & Beverages
Status: Closed
Closeout Letter: February 22, 2023

Summary

Myllan-ORA ehf, an Icelandic seafood processor, failed to comply with federal Hazard Analysis and Critical Control Point (HACCP) regulations for its ready-to-eat herring and refrigerated lumpfish caviar products. The company's HACCP plan did not identify necessary critical control points (CCPs) required to control food safety hazards, including the failure to establish receiving procedures with critical limits to prevent toxin formation from Clostridium botulinum and Staphylococcus aureus in refrigerated salted caviar. As a result, the FDA determined the products were adulterated and prepared under conditions that could render them injurious to health. The company had not responded to the FDA-483 Inspectional Observations issued at the conclusion of the May 2022 inspection.