Company
CanadaUsine Rotec Inc, Baie-du-febvre, Canada – FDA Inspections
Inspection records and compliance data for Usine Rotec Inc in Baie-du-febvre. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected August 30, 2012.
Company Profile
This profile covers Usine Rotec Inc based in Baie-du-febvre, Canada.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected August 30, 2012.
Most cited issue areas
- Design review procedures - personnel1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 802743 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Usine Rotec Inc
FEI Number
3001752600
Address
125 De L'eglise St, Baie-du-febvre, Canada
Country
Canada
ID: 972112c0-dd25-43e9-bd06-db20b61a8b30