FDA Inspection 1239007 — Zenara Pharma Private Ltd
The FDA completed an inspection of Zenara Pharma Private Ltd on May 21, 2024 in Hyderabad. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 21, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |