Warning letter
Synthes, Inc.: warning letter of Nov 5, 2004
FDA warning letter UCM146924 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM146924 |
|---|---|
| Company | Synthes, Inc. |
| Subject | CGMP/QSR/Medical Device Reporting/Adulterated |
| Issue date | Nov 5, 2004 |
| Posted date | Nov 5, 2004 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.52, 803.56, 803.17(a)(2), 803.18(b)(1)(i), 803.50(a)(1), 803.52(b)(5), 807.81(a)(3)(ii), 812.20(a)(2), 820, 803.20(c)(2), 807.81(b) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
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: