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FDA Sends Warning Letters To Three Food Companies

A French-owned bakery in Seattle, a juice processor in Melville, NY, and a seafood processing facility in San Juan Bautista, CA are subjects of recent warning letters from the U.S Food and Drug Administration (FDA).

On April 18, FDA warned Biofournil of America, Inc. about its Seattle bakery after an inspection documented numerous violations of Current Good Manufacturing Practice regulations for the manufacturing, packing, or holding of human food.

Among specific violations observed were pest on the premises, including dead insects in the baking and proofing area and live insects under the wall of a baking oven. Mouse excreta and urine stains were also found in abundance.

The inspection also found equipment and utensils were not being maintained or used properly, such as a dough hook being suspended in an elevated waste-water drain.

Transparent plastic bags were being used repeatedly for dough production, and contained bits of dried dough. Soiled triangular cardboard cutouts were being used as patterns for croissants.

Further, toxic compounds were not properly stored, employee hand washing facilities were inadequate, and the plant and facility had problems when it came to keeping the bakery clean and in good repair.

On April 26, FDA sent a 7-page warning letter to Melville, NY-based Sirob Imports Inc. about its Lindenhurst, NY manufacturing facility for acidified foods and juice products. FDA said its inspection found serious violations, including insanitary conditions of filth that cause adulteration of the products being produced there.

The company did respond to the agency’s Form 483 Inspectional Observations report, but the warning letter says FDA was not provided with any supporting documentation and the manufacturer has a history of promising corrective actions, but not taking them.

The warning letter then goes on to outline the company’s extensive regulatory shortcomings in the areas of acidified foods, juice Hazard Analysis and Critical Control Point plans, and Current Good Manufacturing Practices.

On May 1, FDA sent a warning letter to Pacific Harvest Seafood based in San Juan Bautista, CA over serious violations of seafood HACCP regulations. “Accordingly, your seafood products, including fresh, refrigerated scombroid finfish Mahi Mahi and ready-to-eat refrigerated, cooked Dungeness Crabmeat in hermetiucally sealed containers, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the warning letters says.

In addition to saying Pacific Harvest must have a HACCP for each species of fish it processes, FDA called out the company’s “transit control strategies.” The agency is concerned about transit times for fish taking too long and that fish delivered in open-bed trucks being completely covered in ice.

FDA gave each company receiving a warning letter 15 business days to respond.

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