FDA 483 - McKenna Labs Inc - March 05, 2020

McKenna Labs Inc, a drug product manufacturer in Fullerton, CA, was inspected by the FDA from March 2-5, 2020. The inspection revealed significant deficiencies across laboratory controls, quality control unit procedures, employee training, and manufacturing records. Key issues included incomplete laboratory data, unwritten and unfollowed QC procedures, inadequately trained personnel, and incomplete master and batch production records.