FDA 483 - jones drug company, inc. - September 29, 2015

An FDA inspection conducted from September 22-29, 2015, at Jones Drug Company, Inc. dba Reed's Compounding Pharmacy, identified significant deficiencies in its production of sterile drugs, as outlined in a Form FDA 483. The inspection highlighted numerous violations of Good Manufacturing Practices (GMP) under the Federal Food, Drug, and Cosmetic Act. Key issues included inadequate validation of sterilization processes, with media fill studies failing to represent worst-case conditions and lacking proper documentation. Environmental monitoring was found deficient due to inadequate sampling, inconsistent monitoring during sterile operations, and improper handling of test media. Personnel gowning practices were unsuitable, involving non-sterile protective equipment and reuse of gowns. Further observations detailed insufficient cleaning and disinfection, uncalibrated equipment, and a lack of procedures for HEPA filter changes. Laboratory controls were criticized for inadequate visual product examination and improper pH meter calibration. Batch production records were incomplete, missing critical container information, and showed undocumented deviations from master formulas, including the use of expired raw materials. The firm also failed to thoroughly investigate out-of-specification results and review recall records. Employee training was insufficient, lacking records and verification of effectiveness. Finally, facility controls were absent, including a pest control program (evidenced by dead insects near sterile areas), and there was inadequate material flow and segregation, leading to contamination risks. The company is required to promptly address these observations with comprehensive corrective and preventive actions.