FDA Inspection
IT Dr. Gambert GmbhIT Dr. Gambert Gmbh – FDA Inspection, Jan 27, 2011
Record Details
This FDA Inspection record concerns IT Dr. Gambert Gmbh, with an inspection on January 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- IT Dr. Gambert Gmbh
- Inspection Date
- January 27, 2011
- Product Type
- Devices
View Company Profile
ID · 7e25c3cd-0c3b-4209-ace3-0d2f4cc37a41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709723
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
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.