Warning letter
Tetracore, Inc. [ARCHIVED]: warning letter of Dec 1, 2009
FDA warning letter 86204 · Baltimore District Office
Key facts
| Reference number | 86204 |
|---|---|
| Company | Tetracore, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 1, 2009 |
| Posted date | Dec 1, 2009 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820, 820.1 |
| Inspection city | Rockville |
| Inspection ZIP | 20850 |
| Inspection start date | May 21, 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: