FDA Inspection 1251190 — Empower Clinic Services, LLC dba Empower Pharmacy
The FDA completed an inspection of Empower Clinic Services, LLC dba Empower Pharmacy on October 4, 2024 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 4, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22733 | FDCA 501(a)(2)(A) | Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination |
| 22736 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical, ingredients/processing aides |
| 22749 | FDCA 501(a)(2)(A) | Production areas, difficult to clean/particle generating |
| 22760 | FDCA 501(a)(2)(A) | Failure to clean and disinfect/sterilize equipment, ISO 5 area |
| 22763 | FDCA 501(a)(2)(A) | Lack of/inadequate, environmental monitoring |
| 22765 | FDCA 501(a)(2)(A) | Lack of, routine certification of the ISO 5 |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |