Warning letter
Convatec: warning letter of Apr 18, 2005
FDA warning letter UCM075373 · New Jersey District Office
Key facts
| Reference number | UCM075373 |
|---|---|
| Company | Convatec |
| Subject | Quality System Regulation/Adulterated |
| Issue date | Apr 18, 2005 |
| Posted date | Apr 18, 2005 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803, 820 |
| Country | 3 |
| Inspection city | Greensboro |
| Inspection ZIP | 27409-9403 |
| Inspection start date | Jan 27, 2005 |
| 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: