Warning letter
Ortho Clinical Diagnostics Americas: warning letter of Dec 17, 1999
FDA warning letter UCM067957 · Los Angeles District Office
Key facts
| Reference number | UCM067957 |
|---|---|
| Company | Ortho Clinical Diagnostics Americas |
| Subject | Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling |
| Issue date | Dec 17, 1999 |
| Posted date | Dec 17, 1999 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 606, 606.40, 606.100, 606.160, 606.160(a) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 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: