From August 19-26th the FDA inspected a ready-to-eat (RTE) candies and snack food manufacturing facility located in Arizona, called Cerreta Candy Company. The inspection resulted in the FDA issuing of a Warning Letter to the company. During inspection FDA investigators found numerous severe violations which led them to determine that the products manufactured at the facility were adulterated. There were no labeling violations on this one, but the cGMP violations were numerous.
So now let’s dive into the violations listed in the Warning Letter released.
- They failed to implement an effective food safety plan.
- The hazard analysis that was implemented failed to fully evaluate the facility, products, as well as the raw material ingredients used to manufacture. For example, potential hazards such as Salmonella spp., drug residues, pesticides and heavy metals were left off of the hazard analysis, which shows a lack of control within the facility.
- Many of the RTE products have direct employee contact which elevates the exposure to environmental pathogens. Employees manipulate product from conveyer belts, bulk packaging, and more. The facility lacked evaluations of these foreseeable hazards and documented monitoring.
- Supplier Verification programs are key for production facilities to gain control of an ingredient prior to manufacturing finished product. However, the suppliers need to provide documentation supporting that hazards have been identified and controlled. At this facility in regards to the peanuts used Salmonella spp. was identified as a hazard that was controlled with the supplier, however during the FDA inspection it was determined that the supplier DID NOT control the hazard and explicitly stated such on packaging. Thus, the manufacturing facility was now in charge of controlling that hazard, which it did not.
- The plant also did not document the monitoring of allergens during the changeover of peanut containing product and almond containing one. There is a motto in the industry in regards to the way the FDA views records… “If it isn’t documented, it never happened,” which is precisely the issue here. The company may have actually performed the proper sanitation procedures, however due to the lack of documentation the FDA frankly doesn’t believe it happened.
- The company also did not take effective measures to exclude pests from the plant and protect the food against contamination.
- Rodent excrement was found on the floor where packaging material was stored, on pallets where re-work material was located, as well as in the cold room storage.
- There was apparent gnaw marks where raw material and finished products were stored.
To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.