FDA inspection
Galentic Pharma (India) Pvt. Ltd: FDA inspection ending Feb 14, 2020
FDA inspection 1118660 · Official Action Indicated (OAI) · Gandhidham
Key facts
| Inspection ID | 1118660 |
|---|---|
| Firm | Galentic Pharma (India) Pvt. Ltd |
| FEI number | 3012178852 |
| Address | Plots 5B & 5C, Sector III, Kandla SEZ |
| City | Gandhidham |
| Country | India |
| Fiscal year | 2020 |
| Inspection end date | Feb 14, 2020 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data