Warning letter
Conformis Inc.: warning letter of Dec 10, 2019
FDA warning letter 596362 · Office of Medical Device and Radiological Health Operations
Key facts
| Reference number | 596362 |
|---|---|
| Company | Conformis Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 10, 2019 |
| Posted date | Dec 17, 2019 |
| Issuing office | Office of Medical Device and Radiological Health Operations |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Wilmington |
| Inspection ZIP | 01887 |
| Inspection start date | Sep 16, 2019 |
| Letter on fda.gov | fda.gov |
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: