Create a free Manufacturing.net account to continue

FDA Seeks Injunction Against Pacific Shellfish, Inc.

The FDA has charged Pacific Shellfish, Inc. with violating the Federal Food, Drug, and Cosmetic Act by permitting ready-to-eat fish held and processed in Pacific Shellfish's facility to become contaminated.

The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pacific Shellfish, Inc., a seafood processor in San Diego, CA, and Judd J. Brown, its President.

The government's compliant, filed Jan. 24, 2006 by the U.S. Dept. of Justice in the U.S. District Court for the Southern District of California, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by permitting ready-to-eat fish held and processed in Pacific Shellfish's facility to become contaminated.  

According to the complaint, recent FDA inspections in 2004 and 2005 revealed the presence of Listeria monocytogenes (Listeria), a disease-causing bacterium, on Pacific Shellfish's processing equipment and fish products. Inspections since 2001 have also documented persistent insanitary conditions at the facility.

The FDA issued a letter to Pacific Shellfish on Dec. 8, 2004, after an inspection revealed insanitary conditions and contamination with Listeria. Although Pacific Shellfish promised to correct the deficiencies, a 2005 inspection found that a persistent strain of Listeria remained and they had not implemented all of the promised corrections.

The injunction prohibits a firm from manufacturing, distributing, processing, or shipping a product.

        An unexpected error occurred: Timed out after 10000ms
      
More