FDA Inspection 1091278 — OrBion Pharmaceuticals Private Limited
The FDA completed an inspection of OrBion Pharmaceuticals Private Limited on May 31, 2019 in Chennai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 31, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3586 | 21 CFR 211.110(a)(1) | Tablet or capsule weight variation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |