The facility’s HACCP plan did not include the required criteria for control measures delivering a 5-log reduction in the most heat-resistant microorganisms of public health concern to be in place at least as long as the product shelf life. Additionally, the process was not validated against Cryptosporidium parvum, E. coli O157:H7, and Salmonella. … Continue readingJuice Company Receives Warning Letter for HACCP Violations

The FDA warning letter stated that the importer did not ensure that the seafood items they imported were in compliance with Seafood HACCP.  This includes ensuring that the hazards of parasites and aquaculture drugs are controlled, and extends to specific species-related hazards including histamine. … Continue readingFDA Warning Letter: Imported Foods Must Meet All Applicable U.S. Regulations

An incomplete Food Safety Plan hazard analysis, which did not identify and evaluate pathogenic bacteria, e.g., Salmonella, despite use of ingredients that have been associated with Salmonella concerns in the past. Because of this, no preventive controls (e.g., processes such as a lethality treatment or a supply chain program) against pathogenic bacteria were identified. … Continue readingForeign Food Facility Receives Warning Letter for Unsanitary Conditions

Food facilities are required to renew their FDA registrations on a bi-annual basis. As shown by this facility’s warning letter, failure to do so can elicit a citation or other consequence … Continue readingReady-to-eat Prepared Foods Plant Receives FDA Warning Letter for Multiple Violations

Allergen cross contact related to the unintended presence of sesame was not fully considered and managed with sanitation not extended to all shared equipment or the sanitation procedure, as written in the Food Safety Plan, not addressing which equipment was to be cleaned nor its frequency. Additionally, sesame residue was observed after sanitation had been completed. … Continue readingBakery Receives FDA Warning Letter for Inadequate Allergen Controls

A recent Warning Letter was sent to a sprouts producer due to its failure to comply with the FSMA Produce Safety Rule. Violations included: … Continue readingSprouts Grower Fails to Comply with FSMA Produce Safety Rule