Warning letter
CooperSurgical, Inc.: warning letter of Jun 9, 2015
FDA warning letter 449979 · New England District Office
Key facts
| Reference number | 449979 |
|---|---|
| Company | CooperSurgical, Inc. |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Jun 9, 2015 |
| Posted date | Jun 16, 2015 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.50(a)(2), 807.81(a)(3)(ii), 807.81(b), 890.5710 |
| Inspection city | Trumbull |
| Inspection ZIP | 06611 |
| Inspection start date | Nov 14, 2014 |
| 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: