FDA Inspection 1261213 — Revive Rx LLC dba Revive Rx Pharmacy
The FDA completed an inspection of Revive Rx LLC dba Revive Rx Pharmacy on February 7, 2025 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 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 |