FDA Inspection 1004955 — Galentic Pharma (India) Pvt. Ltd
The FDA completed an inspection of Galentic Pharma (India) Pvt. Ltd on Feb 24, 2017 in Gandhidham. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gandhidham (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |