FDA Inspection
Perouse MedicalPerouse Medical – FDA Inspection, Nov 21, 2013
Record Details
This FDA Inspection record concerns Perouse Medical, with an inspection on November 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Perouse Medical
- Inspection Date
- November 21, 2013
- Product Type
- Devices
View Company Profile
ID · 70f6267d-b431-48b7-a24f-df189d57a294
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 857492
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Perouse Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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