Warning letter
Innovative Sterilization Technologies LLC: warning letter of Mar 20, 2019
FDA warning letter 524761 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 524761 |
|---|---|
| Company | Innovative Sterilization Technologies LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Mar 20, 2019 |
| Posted date | Aug 20, 2019 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(ii), 880.6850, 807.81(b) |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: