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Apr 16

FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies

On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from engaging in any manufacture or distribution of fish and fish products until it has remedied certain hazardous conditions in its facilities. Yamaya USA, Inc., the company at issue, was alleged to have been preparing its fish and fish products in facilities contaminated with the pathogen Listeria monocytogenes. For more information about this bacteria, please see our previous report here. In addition to the charge, Yamaya was alleged to be non-compliant with other FDA regulations, including current Good Manufacturing Practice (cGMP) and the hazard analysis critical control point (HACCP) regulations applicable to seafood producers.

Prior to the consent decree, the FDA issued a Warning Letter to Yamaya in July 2011. Found here, the Warning Letter outlines the various deficiencies allegedly found at Yamaya’s facilities during an FDA inspection. While not alleging the presence of Listeria monocytogenes, the Warning Letter shows that the company was previously warned that it was not in compliance with various regulations pertaining to seafood manufacturers, including cGMPs and HACCP regulations Warning letters, typically FDA’s first course of action against parties deemed noncompliant with federal regulations, are a type of informal agency action that is used to signal the possibility of future enforcement should the alleged deficiencies not be remedied. Thus, it is important to take warning letters seriously and complete any necessary corrective actions in order to thwart the possibility of further agency action.

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