Warning letter
Nuvolase Inc.: warning letter of May 8, 2014
FDA warning letter 416360 · San Francisco District Office
Key facts
| Reference number | 416360 |
|---|---|
| Company | Nuvolase Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | May 8, 2014 |
| Posted date | May 20, 2014 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820, 807.81(a)(3)(ii), 807.81(b) |
| Inspection city | Los Angeles |
| Inspection ZIP | 90024 |
| Inspection start date | Aug 28, 2013 |
| 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: