FDA Inspection 1094298 — Agon Pharma Private Limited
The FDA completed an inspection of Agon Pharma Private Limited on Jun 13, 2019 in Yawat. 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
- Jun 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yawat (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |