FDA Inspection
INNOVIEW GMBHINNOVIEW GMBH – FDA Inspection, Sep 8, 2011
Record Details
This FDA Inspection record concerns INNOVIEW GMBH, with an inspection on September 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- INNOVIEW GMBH
- Inspection Date
- September 8, 2011
- Product Type
- Devices
View Company Profile
ID · 83942d4a-0ca9-4b13-850c-12056c70b60b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 747417
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of INNOVIEW GMBH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for INNOVIEW GMBH
- FDA Inspection 567235 - 2009-01-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.