FDA Issues Warning to Noodle Manufacturer for Severe Food Safety and GMP Violations
An FDA inspection of a noodle manufacturer found that the facility did not have the required food safety plan and had numerous GMP violations. Specifically
Category: FDA Warning Letters
FDA Issues Warning Letter to Egg Farm for SE Prevention Plan Violations and Biosecurity Failures
A shell egg farm and processing facility being inspected by the FDA to determine compliance to the Shell Egg Regulation (21 CFR Part 118) was
FDA Issues Warning Letter to Texas RTE Seasoning Blends Manufacturer for Lack of Food Safety Plan and GMP Violations
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
FDA Issues Warning Letter to Warehouse Over Pest Infestations and Food Safety Concerns
Pests and situations that could lead to pest infestations were the primary focus of an FDA warning letter sent to a refrigerated, frozen and ambient
FDA Issues Warning Letter to Raw Milk Cheese Manufacturer for Sanitation and Listeria Concerns
In its inspection of a raw milk cheese manufacturer, FDA inspectors detected repeated incidence of Listeria monocytogenes (Lm) and other Listeria species in the environment
FDA Issues Warning Letter to RTE Bakery: Serious Violations of CGMPs and PC Rule Uncovered
Serious violations of CGMPs and the PC Rule, along with multiple instances of Listeria species in the production environment, of an RTE bakery caused FDA
FDA Issues Warning Letter to RTE Baby Food Manufacturer
It was violations of GMPs, Hazard Analysis, and Human Foods Preventative Control that lead to a warning letter for a manufacturer of refrigerated ready-to-eat baby
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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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. …
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. …
