Got a 483? Don’t Let it Escalate into a Warning Letter
It’s not all that unusual for a firm to get a Form 483 following an FDA inspection. Occasionally when the FDA considers the firm’s response
It’s not all that unusual for a firm to get a Form 483 following an FDA inspection. Occasionally when the FDA considers the firm’s response
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. …
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. …
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 …
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. …
A recent Warning Letter was sent to a sprouts producer due to its failure to comply with the FSMA Produce Safety Rule. Violations included: …
Spice Importer Failed to Comply with FSVP Requirements; FSVP requires that importers identify and evaluate known or reasonably foreseeable hazards for each type of imported food to determine if there are any that require a preventive control. …
FDA Warning letter was received by an RTE Bakery with deficiencies in Pests and Facility Registration …