FDA 483 - H J Harkins Company Inc dba Pharma Pac - March 03, 2023

H J Harkins Company Inc dba Pharma Pac, a drug repacker in Grover Beach, CA, was inspected by the FDA from February 27 to March 3, 2023. The inspection revealed significant deficiencies in quality control unit procedures, including lack of written procedures for vendor qualification, training, recall processes, and customer complaints. Additionally, the firm lacked a stability testing program, annual batch evaluations, and proper calibration records for equipment.