FDA Inspection 1278378 — ProRx LLC
The FDA completed an inspection of ProRx LLC on September 19, 2025 in Exton, PA. 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
- September 19, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Exton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |