Warning letter
Radiometer America, Inc.: warning letter of Oct 12, 2006
FDA warning letter UCM076103 · Cincinnati District Office
Key facts
| Reference number | UCM076103 |
|---|---|
| Company | Radiometer America, Inc. |
| Subject | Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation |
| Issue date | Oct 12, 2006 |
| Posted date | Oct 12, 2006 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.10, 806.2(d), 806.10(a)(1), 820, 806.10(b) |
| Country | 3 |
| Inspection city | Westlake |
| Inspection ZIP | 44145-1521 |
| Inspection start date | Mar 10, 2006 |
| 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: