Warning letter
Gunnell, Inc. [ARCHIVED]: warning letter of Nov 9, 2010
FDA warning letter 131691 · Detroit District Office
Key facts
| Reference number | 131691 |
|---|---|
| Company | Gunnell, Inc. [ARCHIVED] |
| Subject | Premarket Approval/Adulterated/Misbranded |
| Issue date | Nov 9, 2010 |
| Posted date | Nov 9, 2010 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b), 803.17, 803, 820, 820.40 |
| Inspection city | Elk City |
| Inspection ZIP | 73644 |
| Inspection start date | Jun 7, 2010 |
| 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: