FDA 483 - Buderer Drug Company Inc - January 04, 2016

The FDA issued a Form 483 to Buderer Drug Company Inc. following an inspection conducted from December 14, 2015, to January 4, 2016. The inspection revealed significant deficiencies in the company's manufacturing processes for sterile drug products, indicating non-compliance with current Good Manufacturing Practices.Key observations included inadequate air supply in aseptic processing areas, specifically the ISO 5 compounding area. Environmental monitoring, encompassing surface, viable and non-viable air, and personnel monitoring for the ISO 5 area, was not performed daily. The FDA also noted that equipment and utensils were not properly maintained or sanitized, and there was a lack of data to support the storage of glassware in unclassified areas. Furthermore, approved components were not retested or reexamined for identity, strength, quality, and purity after long storage periods, with no data to support the three-month expiration date assigned to components used in sterile drug products. Most critically, each batch of sterile and pyrogen-free drug product, including those intended for intrathecal administration, was not laboratory tested for sterility and endotoxin conformance.These observations highlight critical gaps in contamination control, quality assurance, and product release testing. Buderer Drug Company Inc. is required to address these deficiencies to ensure the safety, identity, strength, quality, and purity of its sterile drug products, demonstrating a robust commitment to regulatory compliance.