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The findings of a resident strain of Salmonella Enteritidis (SE) in a Georgia shell egg farm and processing facility and serious violations of the shell egg regulation (21 CFR 118) during an FDA investigation caused inspectors to render shell eggs adulterated and issue a Form 483.
FDA Warning Letters

FDA Issues Warning Letter to Shell Egg Farm and Processing Facility

The specific allegations in the warning letter included detail of the ineffective compliance with the regulation resulting in the serious violations were:
• A resident strain of Salmonella was found in the facility and included some isolates that matched clinical isolates. The pathogen was detected by swab samples taken in the poultry houses which tested positive for SE. Additionally, SE had been previously found across multiple years in these areas, and the species isolates matched several clinical isolates in reference databases.
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If you have or are importing from a foreign facility, it is important to know that FDA can issue 483s through a Foreign Remote Regulatory Assessment, and follow up with a Warning Letter if the facility does not respond to the 483, as was the case with a seafood processor in Indonesia. FDA found the facility to have serious violations of the Seafood HACCP regulations
FDA Warning Letters

FDA Issues Warning Letter Through a Foreign Remote Regulatory Assessment

The Hazard Analysis was not complete since the hazard of pathogen growth, including Salmonella, which can pose risks in this situation, was not addressed.

The critical limits included in the HACCP Plan were not deemed adequate to prevent the formation of histamine, which can cause serious symptoms within minutes or hours of consumption. Histamine is a heat-stable toxic metabolite produced by certain bacteria found in some fish species that can be formed if the fish are not properly refrigerated. … Continue readingFDA Issues Warning Letter Through a Foreign Remote Regulatory Assessment

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A lack of effective pest control and the resulting pest contamination found during an FDA inspection caused the ambient, refrigerated and frozen food warehouse to receive 483 citations
FDA Warning Letters

FDA Warning Letter Issued to Warehouse for Infestation

Violative observations from the inspection included ineffective measures to exclude pests, as evidenced by abundant sightings throughout the warehouse of

Rodent excreta pellets and urine stains in numerous places on pallets of food, packaging materials, storage areas, support beams, floors, etc.; dead, decomposed rodents in traps; rodent paw and tail prints; and missing rodent stations.

Bird excreta on pallets and nesting material.

Live insects. … Continue readingFDA Warning Letter Issued to Warehouse for Infestation

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The issuance of a warning letter to a California juice company illustrates the importance of following all regulations applicable to your food business and responding in full, with corrective actions, to an FDA-issued 483.
FDA Warning Letters

Juice Company Receives Warning Letter for HACCP Violations

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

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The FDA citation for lack of a food safety plan included the fact that the facility had not conducted a hazard analysis which would have identified where preventive controls, and their associated elements were needed.
FDA Warning Letters

FDA Warning Letter: Imported Foods Must Meet All Applicable U.S. Regulations

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

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Earlier this year, the FDA inspection of a food facility in India found the company’s RTE mouth fresheners to be adulterated due to unsanitary conditions and failure to comply with provisions of the CGMP & PC rule.
FDA Warning Letters

Foreign Food Facility Receives Warning Letter for Unsanitary Conditions

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

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A bakery was recently cited for inadequate allergen controls related to sesame, and failure to comply with FSMA preventive control provisions and GMPs
FDA Warning Letters

Bakery Receives FDA Warning Letter for Inadequate Allergen Controls

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

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