# FDA 483 - Empower Pharmacy - August 28, 2024

Source: https://www.keypedia.com/records/483/empower-pharmacy/f939ad83-07a4-4ef3-9089-a13e08bb6811

> FDA 483 for Empower Pharmacy on August 28, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empower Pharmacy
- Inspection Date: 2024-08-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/empower-pharmacy/d0830ab6-58b6-4661-95a6-31c44f7c46fe

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c