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

H J Harkins Company Inc dba Pharma Pac, a drug repacker, was inspected by the FDA from February 27 to March 3, 2023. The inspection identified several critical deviations from current Good Manufacturing Practices (CGMP), indicating a deficient quality management system. Key issues included the quality control unit's failure to adhere to written procedures, verify product counts for Ciprofloxacin HCl, maintain records of recall notifications for products like acetaminophen, or establish a written procedure for handling customer complaints. Additionally, the firm had not conducted required CGMP training for its quality unit personnel since 2020. Significant gaps were also noted in product stability testing, as the company lacked a written program and data for repacked drug products in various container-closure systems, such as Tramadol HCl. The facility also failed to conduct annual evaluations of batch records for repacked items and lacked calibration records for essential equipment, including thermometer sensors in the drug storage room, where temperature-sensitive bulk drugs are stored. The FDA 483 document serves as notification of these objectionable conditions. H J Harkins Company Inc dba Pharma Pac is required to investigate these observations thoroughly and implement comprehensive corrective and preventive actions to comply with the Federal Food, Drug, and Cosmetic Act and ensure drug product quality and patient safety.