Warning letter
Endotec, Inc. [ARCHIVED]: warning letter of Oct 22, 2009
FDA warning letter 75024 · Florida District Office
Key facts
| Reference number | 75024 |
|---|---|
| Company | Endotec, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Adulterated/Misbranded |
| Issue date | Oct 22, 2009 |
| Posted date | Oct 22, 2009 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 806.10(c)(5), 820, 820.40, 806.10(b) |
| Inspection city | Santa Fe Springs |
| Inspection ZIP | 90670 |
| Inspection start date | May 18, 2009 |
| 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: