Warning letter
Defibtech, LLC: warning letter of Apr 24, 2007
FDA warning letter UCM076367 · New England District Office
Key facts
| Reference number | UCM076367 |
|---|---|
| Company | Defibtech, LLC |
| Subject | CGMP for Medical Devices/QS/Adulterated |
| Issue date | Apr 24, 2007 |
| Posted date | Apr 24, 2007 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Country | 3 |
| Inspection city | Guilford |
| Inspection ZIP | 06437-2714 |
| Inspection start date | Mar 5, 2007 |
| 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: