Warning letter
Gottfried Medical, Inc.: warning letter of Apr 27, 2015
FDA warning letter 456882 · Cincinnati District Office
Key facts
| Reference number | 456882 |
|---|---|
| Company | Gottfried Medical, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 27, 2015 |
| Posted date | Apr 27, 2015 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 820, 803, 820.40 |
| Inspection city | Toledo |
| Inspection ZIP | 43617 |
| Inspection start date | Mar 9, 2015 |
| 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: