FDA Inspection 1261615 — Nitro Quimica Corporation
The FDA completed an inspection of Nitro Quimica Corporation on Feb 21, 2025 in College Park, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- College Park, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |