Warning letter
C Change Surgical, LLC: warning letter of Sep 24, 2008
FDA warning letter UCM1048126 · Atlanta District Office
Key facts
| Reference number | UCM1048126 |
|---|---|
| Company | C Change Surgical, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 24, 2008 |
| Posted date | Sep 24, 2008 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 807.81, 820, 820.40, 807.81(b) |
| Country | 3 |
| Inspection city | Winston Salem |
| Inspection ZIP | 27101-4046 |
| Inspection start date | Mar 11, 2008 |
| 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: