FDA Inspection 983873 — Solara Active Pharma Sciences Limited
The FDA completed an inspection of Solara Active Pharma Sciences Limited on Aug 31, 2016 in Chennai. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 31, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |