Warning letter
Bellus Medical: warning letter of Sep 13, 2016
FDA warning letter 495955 · Dallas District Office
Key facts
| Reference number | 495955 |
|---|---|
| Company | Bellus Medical |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Sep 13, 2016 |
| Posted date | Oct 3, 2016 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 807.97, 878.4820, 807.81(b), 878.9(b) |
| Inspection city | Johnson City |
| Inspection ZIP | 37604 |
| Inspection start date | Mar 21, 2016 |
| 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: