FDA Inspection
Usine Rotec IncUsine Rotec Inc – FDA Inspection, Aug 30, 2012
Record Details
This FDA Inspection record concerns Usine Rotec Inc, with an inspection on August 30, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Usine Rotec Inc
- Inspection Date
- August 30, 2012
- Product Type
- Devices
View Company Profile
ID · a6c87908-cbc3-40df-b1c1-9cc2ec30b38e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 802743
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.100(a)Lack of or inadequate procedures
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