FDA 483 - McKenna Labs Inc - February 13, 2025

McKenna Labs Inc, a contract manufacturer in Fullerton, CA, was inspected by the FDA from February 10-13, 2025. The inspection revealed significant deficiencies in batch production and control records, specifically regarding critical process parameters for OTC drug products, and in laboratory records where calculations and raw data for identity testing and yield were incomplete or not properly recorded. These issues indicate a lack of adequate control over manufacturing and testing processes.