Warning letter
Acclarent, Inc.: warning letter of Mar 20, 2013
FDA warning letter 394263 · San Francisco District Office
Key facts
| Reference number | 394263 |
|---|---|
| Company | Acclarent, Inc. |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Mar 20, 2013 |
| Posted date | Mar 20, 2013 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.10(a) |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Jan 29, 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: