FDA-483 Issued After Cantrell Drug Co. Inspection

FDA has issued a Form FDA-483 after an August inspection of a Cantrell Drug Co. outsourcing facility in Little Rock, AR. According to the FDA-483, buildings used in manufacturing, processing, packing, or holding of drug products did not have the suitable construction to facilitate cleaning, maintenance, and proper operations. FDA investigators also found that equipment for controlling humidity was not used appropriately. Specifically, the upper action limit for relative humidity for ISO rooms was set at a level without scientific rationale. Additionally, appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records were instituted only by authorized personnel. For example, Excel spreadsheets used to maintain data for trending data including non-conformances, weight checks and environmental monitoring data did not have adequate controls to prevent manipulation and storage of data.