FDA 483 - Delta Pharma, Inc. - October 02, 2013

An FDA inspection of Delta Pharma, Inc., a producer of sterile drugs located in Ripley, MS, was conducted from September 24 to October 2, 2013. The inspection resulted in nine significant observations detailed in an FDA Form 483, indicating deviations from current Good Manufacturing Practices. The primary concerns revolved around the company's inadequate procedures for preventing microbiological contamination of sterile drug products. Specifically, the FDA noted a lack of validation for sterilization processes, including media fills, sterilization cycles for finished products and components, and container washing/depyrogenation. Environmental monitoring in aseptic processing areas was also cited for deficiencies, such as unvalidated smoke studies, insufficient surface and air particulate monitoring, and inconsistent personnel monitoring. Furthermore, issues were identified with the design and operation of aseptic processing cleanrooms, including inadequate pressure differential measurement and lack of HEPA filter integrity testing. The inspection also revealed that critical manufacturing equipment, including depyrogenation ovens and incubators, were not properly qualified or calibrated. Personnel gowning practices and the sanitization of cleanroom equipment and materials were found to be deficient, with non-sterile cleaning agents and unvalidated dilution protocols being used. Repeated observations from previous inspections highlighted long-standing issues with sterilization validation, equipment qualification, raw material testing, and supplier qualification. Delta Pharma, Inc. is expected to address these observations by implementing comprehensive corrective actions to ensure compliance with federal regulations governing sterile drug manufacturing.