FDA Inspection
Suzanne T Ildstad MDSuzanne T Ildstad MD – FDA Inspection, Sep 16, 2009
Record Details
This FDA Inspection record concerns Suzanne T Ildstad MD, with an inspection on September 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Suzanne T Ildstad MD
- Inspection Date
- September 16, 2009
- Product Type
- Biologics
View Company Profile
ID · adeeec4d-15e9-4a9b-bfb5-3e05488a95bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613890
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.20(a)(2)Initiation of study prior to FDA IDE approval
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(3)Sponsor notification of FDA approval withdrawal
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.