FDA 483 - Pyramid Laboratories, Inc. - January 15, 2015

During an FDA inspection conducted from January 5-15, 2015, Pyramid Laboratories, Inc., a sterile drug and biologic manufacturer, was issued a Form FDA 483 detailing thirteen significant observations regarding its compliance with Good Manufacturing Practices (GMP). The inspection revealed systemic deficiencies across multiple areas. Within the Quality System, issues included a failure to investigate numerous environmental excursions and particle events, a lack of formal change control for facility maintenance, and inadequate qualification of component suppliers. The quality control unit also lacked sufficient authority to investigate errors like missed aseptic interventions during media fills. Furthermore, employee training for critical visual inspection tasks was found to be inadequate. Observations related to the Production System highlighted a lack of established time limits and in-process testing for critical buffer solutions, significant deficiencies in environmental monitoring in aseptic processing areas, and insufficient validation of sterilization processes for stoppers. Laboratory controls were cited for lacking suitability testing for sterility methods and inadequate growth promotion testing for culture media. Finally, the Equipment and Facility System had issues with unproven equipment design for vial cleaning and incomplete equipment logs for major manufacturing equipment. These observations indicate a need for comprehensive corrective actions by Pyramid Laboratories, Inc. to ensure the identity, strength, quality, and purity of their drug products and to align their operations with regulatory expectations.