FDA inspection
Syngene USA Inc.: FDA inspection ending Apr 20, 2021
FDA inspection 1141685 · Official Action Indicated (OAI) · Baltimore, MD
Key facts
| Inspection ID | 1141685 |
|---|---|
| Firm | Syngene USA Inc. |
| FEI number | 3015448605 |
| Address | 5901 E Lombard St |
| City | Baltimore |
| State | MD |
| ZIP | 21224 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Apr 20, 2021 |
| Classification | Official Action Indicated (OAI) |
| Project area | Vaccines and Allergenic Products |
| Product type | Biologics |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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