FDA Inspection 1251190 — Empower Clinic Services, LLC
The FDA completed an inspection of Empower Clinic Services, LLC on Oct 4, 2024 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
- Oct 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 |