1094298
Agon Pharma Private Ltd — FEI 3007481629
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pune (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 |