FDA 483 - Empower Pharmacy - November 25, 2015

The FDA Form 483 details significant deficiencies at a facility producing sterile injectable drug products.

**Key Violations and Observations:**

1. **Inadequate Investigation of Batch Failure:** The firm failed to thoroughly investigate a non-sterile result for Lipo-C Injectable, lot #17478, dated 9/10/15, which was contaminated with *Streptomyces galbus*. Despite a contract lab attributing contamination to "external error" and a second sample passing sterility, the firm did not investigate the initial failure or its impact on other lots produced on the same date (e.g., Glutathione, GHRP-2/GHRP-6/Sermorelin).

2. **Insufficient Sterilization Process Validation:** * **Media Fills:** Media fills (SOP #708.06) were not representative of actual production, failing to simulate maximum vial counts, interventions (e.g., spills), aseptic equipment assembly, or API preparation. Lyophilized products (e.g., Human Chorionic Gonadotropin, Sermorelin) lacked media fills. * **Sterilization Equipment:** Validation was not performed for the redacted (Model redacted) used to sterilize rubber stoppers, caps, and forceps. * **Depyrogenation:** The redacted used for glassware depyrogenation lacked studies to determine redacted, despite simulating worst-case conditions.