FDA 483 - Apollo Care, LLC - April 05, 2023

An FDA inspection of Apollo Care, LLC, an outsourcing facility, was conducted from March 7 to April 5, 2023. The inspection revealed significant observations regarding quality control, aseptic processing, and labeling practices, indicating potential non-compliance with drug manufacturing regulations, particularly those related to sterile compounding. Key issues included a failure to thoroughly investigate unexplained discrepancies, such as an 8% HEPA filter leak in an ISO 5 laminar airflow hood which was a repeat observation from 2018. Additionally, investigations into suspect microbial growth were inadequate, lacking proper identification testing, environmental monitoring, and appropriate product impact assessments. In one instance, a product with suspect microbial growth was wiped down and relabeled for distribution. The firm also failed to adequately validate its aseptic processes, evidenced by the absence of media fills for 10 mL syringes, despite commercially compounding and distributing them. Employees were not properly qualified for visual inspection of syringes or critical defects in IV bags relevant to their operations. Furthermore, an employee failed to follow standard operating procedures by not disinfecting a non-sterile beaker before introducing it into an ISO 5 hood. Storage conditions were also noted as deficient, with several drug products not protected from light. Finally, numerous drug product labels were found to be non-compliant, missing essential information such as the established name of the drug, storage and handling instructions, or entirely lacking container labels, as required by Section 503B(a)(10) of the Federal Food, Drug, and Cosmetic Act. Apollo Care, LLC is required to address these observations with prompt and comprehensive corrective actions.