FDA 483 - Sentara Infusion Services - July 23, 2015

During an FDA inspection from July 13-23, 2015, Sentara Enterprises, a Chesapeake, VA-based producer of sterile drug products, received a Form 483 detailing multiple deviations from Current Good Manufacturing Practices (CGMP). The primary issues centered on inadequate aseptic processing, with observed poor operator technique, non-sterile gowning, and insufficient environmental controls. Facilities exhibited maintenance deficiencies, including rust and stains in critical cleanroom equipment. The firm also lacked adequate validation for sterilization processes, specifically regarding filter integrity testing and comprehensive media-fill studies for products derived from non-sterile components. Significant gaps in laboratory controls were identified, including the absence of sterility and endotoxin testing for sterile drug products made from non-sterile materials. Inaccurate incubation temperatures for sterility samples and failure to test for anaerobic microbes were noted. Product expiration dates were not supported by sufficient stability data. Furthermore, the company failed to investigate positive environmental monitoring results, identify contaminants, or establish appropriate alert limits. A crucial incubator lacked calibration records. Sentara Enterprises is required to submit a comprehensive plan of corrective and preventive actions to address these observations and ensure full compliance with sterile drug manufacturing regulations.