FDA Inspection
Ansamed Ltd.Ansamed Ltd. – FDA Inspection, Nov 2, 2011
Record Details
This FDA Inspection record concerns Ansamed Ltd., with an inspection on November 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ansamed Ltd.
- Inspection Date
- November 2, 2011
- Product Type
- Devices
View Company Profile
ID · 01e5ce74-1b41-4aa8-8bde-2ba1b218d593
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755402
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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.