FDA 483 - Empower Pharmacy - August 28, 2024

This FDA Form 483 details nine observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds sterile drug products, including Pyridoxine HCL, Glycine, Testosterone Cypionate, Ascorbic Acid, Lipo-B/Methionine/Choline Chloride/Cyanocobalamin, Glutathione, Ketamine HCl, Testosterone Pellets, and Estradiol Pellets.

**Violations and Observations:**

1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed. * A batch of sterile Pyridoxine HCL was released despite positive microbial growth (Bacillus altitudinis/pumilus/safensis) detected in the ISO 5 area. * Sterile inner bags of vials were opened in the ISO 7 room and introduced into the ISO 5 LAFH without disinfection. * No environmental monitoring (EM) was performed on surface contact samples for tools used to place stoppers. * Smoke studies failed to demonstrate the impact of horizontal gaps and a bar hole in the ISO 5 LAFH on unidirectional airflow. * A full batch of Ascorbic Acid was released despite non-viable particle monitoring exceeding action levels in ISO 5 areas, without a definite root cause identified. * An operator exhibited improper aseptic technique by picking up scissors from the ISO