FDA 483 - Alk-abello, Inc. - August 26, 2022

An FDA inspection conducted at Co-Pak-d Corporation from August 15-26, 2022, identified significant deviations from current good manufacturing practices. Key issues centered on inadequate pest control, facility sanitation, and the implementation of established procedures. Inspectors observed live birds, German cockroaches, flies, and rodent activity, along with structural deficiencies like gaps in dock doors, indicating a failure to exclude pests effectively. The facility also exhibited poor cleanliness, with dried fruit residue on food-contact surfaces, general accumulation of debris, and structural disrepair including peeling paint and cracked floors. Furthermore, cleaning and sanitation of food-contact surfaces were insufficient between production runs, and employees did not adhere to personal hygiene standards like wearing beard guards. Critical failures in control implementation included non-adherence to the company's master sanitation schedule and pre-operational inspection protocols, which documented equipment as clean despite visible residue. Allergen control procedures were not followed during production changes, and the firm's hazard analysis was incomplete, failing to identify mycotoxins and undeclared sulfites as hazards requiring preventive controls, and lacking supply-chain verification. Additionally, frozen ingredients were stored at ambient temperatures for extended periods without adequate procedures. These observations, referenced against 21 CFR regulations, necessitate prompt corrective actions to ensure food safety and regulatory compliance.