FDA 483 - Corey Nutrition Company Inc - June 03, 2022

An FDA inspection of Corey Nutrition Company Inc., conducted from May 30 to June 3, 2022, identified several significant deficiencies, leading to the issuance of an FDA Form 483. The company failed to adequately evaluate known or reasonably foreseeable hazards in its animal food production, specifically citing the biological hazard of Salmonella in incoming materials and the chemical hazard of fumonisin in corn and corn gluten meal used in dog food kibble.

Inspectors observed severe sanitation issues in the receiving area, including heavy accumulations of rancid, solidified material, actively leaking pipes, and a lack of routine cleaning, which could lead to Salmonella contamination. Furthermore, the firm demonstrated ineffective pest exclusion, with rodent excreta found in ingredient storage and a live mouse observed. The facility also exhibited poor maintenance, with evidence of leaks, disrepair, and standing water in storage rooms—a condition noted in a previous 2015 inspection. Finally, corrective action procedures for preventive controls were deemed inadequate, as they lacked provisions to prevent the recurrence of identified problems. These observations indicate conditions where animal food may become adulterated under Section 704(b) of the Federal Food, Drug and Cosmetic Act. Corey Nutrition Company Inc. is expected to respond with comprehensive corrective and preventive actions to address these findings.