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 their sterile drug production practices. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, highlighted multiple areas of non-compliance impacting product sterility and quality.Key violations included inadequate validation of sterilization processes, with media fill studies lacking proper documentation and not representing worst-case scenarios. Environmental monitoring was deficient, showing issues with personnel and cleanroom surface monitoring, lack of an established sampling plan, and incubator temperature deviations. Personnel gowning was found to be inappropriate, with non-sterile attire and repeated use of garments, increasing contamination risk.Cleaning and disinfection procedures were inadequate, using non-sterile wipes and failing to properly clean critical equipment. Calibration of essential equipment, such as balances and thermometers, was lacking. The firm also failed to establish pest control measures, with dead insects observed near sterile production areas.Furthermore, batch production records were incomplete, missing critical information on container closures, and deviations from master records were undocumented. Laboratory controls were insufficient, including poor visual inspection methods and pH meter calibration issues. Employee training records for critical procedures were absent or unverified, and the firm failed to thoroughly investigate out-of-specification results. Finally, facility design issues allowed potential contamination, with un-wiped supplies entering cleanrooms and food items stored near sterile products and environmental monitoring incubators. The company is required to address these observations promptly to ensure patient safety and regulatory compliance.