FDA Inspection 1244125 — Nubratori, Inc
The FDA completed an inspection of Nubratori, Inc on July 26, 2024 in Torrance, CA. 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
- July 26, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 22779 | FDCA 503B(b)(2)(A) | All inclusive product report, not submitted |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |