ImprimisRx NJ – FDA 483, Aug 19, 2013

During an FDA inspection conducted from August 5 to August 19, 2013, Pharmacy Creations, a producer of sterile drug products located in Randolph, NJ, received a Form FDA 483 citing significant observations regarding its manufacturing practices. The inspection revealed several critical deficiencies related to quality control and aseptic processing, indicating a lack of adherence to regulatory expectations for sterile drug production. Key violations included the absence of sufficient testing to establish appropriate expiration dates for drug products, particularly concerning potency and sterility assurance for non-preserved sterile preparations. The company assigned beyond-use dates of up to six months without supporting data and failed to establish container closure integrity. Furthermore, the validation of sterilization processes was found inadequate, with media fill simulations not truly representative of actual aseptic filling operations. The FDA noted that drug product containers were not adequately processed or validated to remove pyrogenic properties. In-house laboratory testing for sterile batches was deficient, lacking proper positive and negative controls for sterility tests, and routine potency and endotoxin testing were not consistently performed. Lastly, environmental monitoring in aseptic processing areas was deemed inadequate, specifically regarding the limited and infrequent monitoring of non-viable particulates. Pharmacy Creations is required to address these observations by implementing comprehensive corrective actions to ensure the safety and quality of its sterile drug products.