FDA 483 - Family Pharmacy of Statesville - March 11, 2022

An FDA inspection of Family Pharmacy of Statesville, Inc. revealed multiple critical deficiencies in aseptic processing and environmental controls for sterile drug production. Observations included inadequate material handling, insufficient disinfection practices, and failures in media fill simulations to challenge aseptic operations. The facility also lacked proper HEPA filtration, failed to verify sterilization cycles, and exhibited poor cleanroom design and maintenance, indicating a significant risk of contamination to sterile products.