Warning letter
Usine Rotec Inc: warning letter of Jan 7, 2013
FDA warning letter 385398 · Center for Devices and Radiological Health
Key facts
| Reference number | 385398 |
|---|---|
| Company | Usine Rotec Inc |
| Subject | Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded |
| Issue date | Jan 7, 2013 |
| Posted date | Jan 7, 2013 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 820.40, 803.50(b) |
| Inspection city | Baie-du-febvre |
| Inspection start date | Aug 27, 2012 |
| 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: