FDA Inspection 1223951 — Empower Clinic Services, LLC
The FDA completed an inspection of Empower Clinic Services, LLC on Dec 1, 2023 in Houston, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 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 |