Warning letter
ConvaTec Inc.: warning letter of May 24, 2013
FDA warning letter 395273 · New Jersey District Office
Key facts
| Reference number | 395273 |
|---|---|
| Company | ConvaTec Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 24, 2013 |
| Posted date | May 24, 2013 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803.52(e)(4), 803.50(b), 803, 803.3, 803.17, 803.52, 803.56, 803.50(a)(1), 803.50(b)(1), 803.52(b)(3), 820 |
| Inspection city | Greensboro |
| Inspection ZIP | 27409 |
| Inspection start date | Jan 8, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: