FDA Inspection 1223951 — Empower Clinic Services, LLC dba Empower Pharmacy
The FDA completed an inspection of Empower Clinic Services, LLC dba Empower Pharmacy on December 1, 2023 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
- December 1, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22738 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical, ingredients/processing aides |
| 22740 | FDCA 501(a)(2)(A) | Personnel infrequently, changed/sanitized gloves |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 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 |
| 22770 | FDCA 501(a)(2)(A) | Failure/inadequate, filter integrity testing |
| 22771 | FDCA 501(a)(2)(A) | Biological indicators, not used |
| 22775 | FDCA 501(a)(2)(A) | Components/containers/materials, endotoxin contamination |