Warning letter
CooperSurgical, Inc. D.B.A. Lone Star Medical Products: warning letter of Apr 25, 2013
FDA warning letter 362439 · Dallas District Office
Key facts
| Reference number | 362439 |
|---|---|
| Company | CooperSurgical, Inc. D.B.A. Lone Star Medical Products |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Apr 25, 2013 |
| Posted date | Apr 25, 2013 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803, 806, 803.50(a)(1), 820, 806.20(a) |
| Inspection city | Stafford |
| Inspection ZIP | 77477 |
| Inspection start date | Jul 10, 2012 |
| 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: