Warning letter
Quantimetrix Corporation: warning letter of May 17, 2007
FDA warning letter UCM076394 · Los Angeles District Office
Key facts
| Reference number | UCM076394 |
|---|---|
| Company | Quantimetrix Corporation |
| Subject | CGMP Requirements for Medical Devices/Quality System Regulation |
| Issue date | May 17, 2007 |
| Posted date | May 17, 2007 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 806.20(b)(4), 803.17, 820 |
| Country | 3 |
| Inspection city | Redondo Beach |
| Inspection ZIP | 90278-1205 |
| Inspection start date | Nov 27, 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: