FDA 483 - IntegraDose Compounding Services LLC - August 02, 2021

During an FDA inspection conducted from July 12 to August 2, 2021, IntegraDose Compounding Services LLC, an outsourcing facility, received a Form FDA 483 detailing significant manufacturing deficiencies. The observations primarily revolved around inadequate procedures to prevent microbiological contamination, including media fills not representative of production and unlogged HVAC discrepancies impacting product release. Aseptic processing areas demonstrated critical deficiencies in cleaning and disinfection, with inspectors noting missed cleaning areas, improper mop and glove changes, incorrect mopping techniques, and failure to observe disinfectant dwell times. Furthermore, apparent rust, dust buildup, and residue were observed on equipment and surfaces within cleanroom areas. The quality control unit was found lacking, with numerous overdue events and corrective actions, a failure to consistently log all events, and unvalidated cleaning dwell times. Deficiencies also included improper qualification of equipment used to control aseptic conditions, such as non-representative smoke studies and a failure to re-qualify hoods after relocation. IntegraDose Compounding Services LLC is expected to promptly address these observations to ensure compliance with regulatory standards for sterile drug product manufacturing.