FDA inspection
Bora Pharmaceuticals Injectables Inc: FDA inspection ending Feb 18, 2022
FDA inspection 1162959 · Official Action Indicated (OAI) · Baltimore, MD
Key facts
| Inspection ID | 1162959 |
|---|---|
| Firm | Bora Pharmaceuticals Injectables Inc |
| FEI number | 1000512361 |
| Address | 1111 S Paca St |
| City | Baltimore |
| State | MD |
| ZIP | 21230 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Feb 18, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 630316 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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