Warning letter
Datascope Corporation: warning letter of Sep 11, 2018
FDA warning letter 562738 · New England District Office
Key facts
| Reference number | 562738 |
|---|---|
| Company | Datascope Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 11, 2018 |
| Posted date | Sep 11, 2018 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(b), 803.50(a)(1), 803.50(a)(2), 820 |
| Inspection city | Fairfield |
| Inspection ZIP | 07004 |
| Inspection start date | Mar 19, 2018 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: