FDA Inspection 1261213 — Revive Rx LLC
The FDA completed an inspection of Revive Rx LLC on Feb 7, 2025 in Houston, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22742 | FDCA 501(a)(2)(A) | Exposed to lower quality air/ISO 5 |
| 22747 | FDCA 501(a)(2)(A) | Microbial contamination was present, ISO 5/areas adjacent |
| 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 |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |
| 22772 | FDCA 501(a)(2)(A) | Lyophilizers, inadequately or not sterilized |