CARNEYS POINT, NJ — The US Food and Drug Administration (FDA) on March 16 issued a warning letter to Bravo Packing, Inc., a dog food manufacturer, for manufacturing violations that caused its raw pet food products to be considered adulterated, as well as the presence of pathogens in some of its finished product.
The agency conducted three follow-up inspections in July and August 2019 after a sample of Performance Dog Food taken during a 2018 inspection tested positive for Salmonella. The follow-up inspections concluded the facility was in violation of the Food, Drug and Cosmetic (FD&C) Act.
Randy Pack, acting district director and acting program division director at the FDA’s Division of Human and Animal Food Operations East II, wrote in the warning letter that the facility displayed “significant violations” to Current Good Manufacturing Practices (cGMPs), Hazard Analysis and Risk-Based Preventive Controls.
cGMP violations include inadequate sanitation of contact surfaces, equipment and utensils, as well as the haphazard use of toxic cleaning materials, inappropriate storage of finished products and insufficient pest control measures in the packing area. The agency also stated the company had not properly educated or trained its employees, based on the agency’s observation of an employee performing sanitation and the facility’s lack of training records.
“The employee also was not instructed or trained to use a degreaser for the removal of residue on the sides of the auger, and on July 22, 2019, the employee stated that he used undiluted bleach on the processing equipment, instead of diluting the bleach properly for use as a sanitizer,” Pack wrote in the letter.
Additionally, the samples taken during the July 24 inspection found one finished product, Performance Dog Food, to contain Salmonella and another, Beef Dog Food, to contain Listeria monocytogenes. The FDA issued a consumer advisory for Performance Dog Food in September 2019 after Bravo Packing was unable to provide the product’s distribution information to the agency.
Bravo Packing made some corrections throughout the course of the July 24 inspection, which the FDA acknowledged. Pack encouraged the company to provide a written response to the agency within 15 days detailing corrective actions and related documentation.
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