FDA Inspection
Gynetics Medical Products NVGynetics Medical Products NV – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Gynetics Medical Products NV, with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gynetics Medical Products NV
- Inspection Date
- June 10, 2010
- Product Type
- Devices
View Company Profile
ID · 2b087032-4f98-4fd9-bf3e-80803c13708a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 671607
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.70(c)Environmental control system-documentation/review inspection
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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