FDA inspection
Datascope Corp.: FDA inspection ending Jan 21, 2022
FDA inspection 1160902 · Official Action Indicated (OAI) · Wayne, NJ
Key facts
| Inspection ID | 1160902 |
|---|---|
| Firm | Datascope Corp. |
| FEI number | 3007965489 |
| Address | 45 Barbour Pond Dr |
| City | Wayne |
| State | NJ |
| ZIP | 07470 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Jan 21, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 10–99 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