FDA 483 - empower clinic services, llc, - December 01, 2023

During an inspection from October 16 to December 1, 2023, the FDA issued a Form 483 to Empower Clinic Services, LLC, dba Empower Pharmacy. The observations primarily highlighted significant deviations from current good manufacturing practices for sterile and non-sterile drug products. Key issues included poor aseptic techniques, such as obstructing "first air" in ISO 5 clean areas, and inadequate personnel practices, like infrequent glove sanitization during critical operations, increasing contamination risks. The company also used active pharmaceutical ingredients (APIs) explicitly labeled "Not for Use As Drug/API, or Drug Product," sourced from unapproved suppliers, for sterile drug production. Further observations noted a lack of adequate cleaning validation for equipment in ISO 5 areas, insufficient environmental monitoring frequency, and a failure to use biological indicators or provide data to verify sterilization cycles and endotoxin control for glassware. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, require Empower Pharmacy to implement corrective actions and provide a response to the FDA addressing each finding to ensure compliance and product safety.