Warning letter
Surgisil, LLP: warning letter of Apr 15, 2019
FDA warning letter 567886 · Office of Medical Device and Radiological Health Operations
Key facts
| Reference number | 567886 |
|---|---|
| Company | Surgisil, LLP |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Apr 15, 2019 |
| Posted date | Apr 30, 2019 |
| Issuing office | Office of Medical Device and Radiological Health Operations |
| Product type | Devices |
| CFR sections cited | 807.97, 878.3500 |
| Inspection city | Plano |
| Inspection ZIP | 75093 |
| Inspection start date | Sep 20, 2018 |
| 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: