FDA Inspection 769956 — Stat Rx USA
The FDA completed an inspection of Stat Rx USA on February 15, 2012 in Gainesville, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gainesville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |