FDA Inspection 1234275 — OneSource Specialty Pharma Limited
The FDA completed an inspection of OneSource Specialty Pharma Limited on Mar 28, 2024 in Bengaluru. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 28, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4576 | 21 CFR 211.192 | No written record of investigation |