Warning letter
Ortho Development Corporation: warning letter of Aug 22, 2001
FDA warning letter UCM178432 · Denver District Office
Key facts
| Reference number | UCM178432 |
|---|---|
| Company | Ortho Development Corporation |
| Subject | Quality System/Good Manufacturing Practice for Medical Devices Regulation/Orthopedic Implants |
| Issue date | Aug 22, 2001 |
| Posted date | Aug 22, 2001 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 803, 806, 820, 806.10(c) |
| Country | 3 |
| Inspection city | Draper |
| Inspection ZIP | 84020-8663 |
| Inspection start date | Jun 5, 2001 |
| 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: