FDA Inspection 1118660 — Galentic Pharma (India) Pvt. Ltd
The FDA completed an inspection of Galentic Pharma (India) Pvt. Ltd on Feb 14, 2020 in Gandhidham. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gandhidham (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |