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 food products in reduced oxygen packaging.
With non-toxin forming Clostridium botulinum isolated from unopened samples from the facility, the business was cited for incomplete hazard analysis because the hazard of Clostridium botulinum growth and toxin formation was not identified. With the lack of identification of the hazard, it was determined that the food did not receive an effective lethal treatment, and did not control growth or toxin formation during expected storage with proper cooler temperatures exceeded and thermometers not calibrated. The hazard analysis also neglected to include the potential for environmental contamination such as Listeria monocytogenes, which can occur when food is exposed at cooling, blending, and filling post process.
Additional issues identified at the cooling step were the use of specific USDA/FSIS cooling parameters differed from those in the FSPCA manual; monitoring was not implemented at the specified frequency; and no corrective action was taken for a deviation from the specified cooling parameter that was noted in the inspection.
Related to GMPs, dripping water from a condenser, standing water on the floor in a cooler where uncovered food was placed, and wet floors with uneven surfaces and holes in the kitchen posed potential food contamination from floors, walls and ceilings. Additionally, misbranding violations were identified related to the declaration of nutrition information, proper ingredient declaration, net quantity, and nutrient claims on the labels.
Reviewing citations from warning letters other businesses have received is a great way to make your team aware of issues you may be overlooking. Taking corrective action before FDA comes to your door will keep you from being cited for similar violations.
