I love when the U.S. Food and Drug Administration lets loose at a food provider that should know better.
In a Feb. letter to the prez of Preferred Meal Systems in Berkeley, Illinois, FDA calmly outlines the complete lack of food safety knowledge at this facility. Excerpts below:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE), cold cut sandwiches and boxed lunches and non-RTE, cooked frozen entrees and side dishes manufacturing facility, located at 4135 Birney Avenue, Moosic, PA, between August 4, 2015 and September 2, 2015.
During our inspection, FDA investigators collected an environmental sample consisting of multiple swabs taken from various areas within your processing facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes (L. monocytogenes) in your facility.
Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR part 110) and the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR part 123).
Based on FDA’s analytical results of the environmental sample and inspectional findings documented during the inspection, we have determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.
The presence of Listeria monocytogenes in your facility is significant in that it demonstrates the sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
On August 27, 2015, FDA informed you of these results. FDA acknowledges your written response to the FDA form 483, Inspectional Observations, on September 23, 2015. However, your response is inadequate. Your response does not provide details of the corrective actions taken where all of the positive swabs were collected in your facility, including subs 131, 137, 149. In addition, your response includes fourteen Certificates of Analyses for environmental swabs collected for Listeria monocytogenes from your facility, all with negative results. The results do not specify the location in the facility where the swab was collected; i.e., whether the swabs were collected from food contact equipment or from the same locations as the positive FDA swabs.
Your firm’s HACCP plan for RTE and NRTE Fish and Fishery Products includes references to the U.S. Department of Agriculture’s (USDA’s) regulations for meat and poultry products. USDA’s regulations do not apply to the seafood products you produce.