Warning letter
Obsidian Medical Technology Inc.: warning letter of Feb 24, 2004
FDA warning letter UCM146222 · San Francisco District Office
Key facts
| Reference number | UCM146222 |
|---|---|
| Company | Obsidian Medical Technology Inc. |
| Subject | Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated |
| Issue date | Feb 24, 2004 |
| Posted date | Feb 24, 2004 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820, 820.5, 820.40 |
| Country | 3 |
| Inspection city | Dublin |
| Inspection ZIP | 94568 |
| Inspection start date | Nov 26, 2003 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: