FDA 483 - American Regent, Inc. - December 09, 2022

The U.S. Food and Drug Administration (FDA) issued a Form 483 to American Regent, Inc., a sterile drug manufacturer in New Albany, OH, following an inspection from December 5 to December 9, 2022. The observations indicate several areas needing improvement to ensure compliance with drug manufacturing regulations. Significant issues were identified regarding procedures to prevent microbiological contamination, noting that media fill studies for sterile drug products were not conducted under operational conditions and failed to include critical interventions. Employee training for manufacturing and processing functions also presented concerns, including uncontrolled access to visual inspection qualification kits, insufficient scientific justification for classifying defects like glass particles, and a lack of established impact assessments for inspection rates. Furthermore, the inspection revealed deficiencies in the firm's investigation processes. Records of investigations into batch failures or discrepancies often lacked complete conclusions and follow-up, exemplified by an unscientifically evaluated yield failure linked to a capping machine issue. These observations necessitate that American Regent, Inc. implement comprehensive corrective actions to address these quality system deficiencies and ensure adherence to federal standards for sterile drug production.