FDA inspection
Datascope Corp.: FDA inspection ending Oct 3, 2018
FDA inspection 1071011 · Official Action Indicated (OAI) · Mahwah, NJ
Key facts
| Inspection ID | 1071011 |
|---|---|
| Firm | Datascope Corp. |
| FEI number | 3001418283 |
| Address | 1300 Macarthur Blvd |
| City | Mahwah |
| State | NJ |
| ZIP | 07430 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Oct 3, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 573566 |
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
- 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