FDA Inspection
Winn, Robert J MDWinn, Robert J MD – FDA Inspection, Sep 8, 2009
Record Details
This FDA Inspection record concerns Winn, Robert J MD, with an inspection on September 8, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Winn, Robert J MD
- Inspection Date
- September 8, 2009
- Product Type
- Biologics
View Company Profile
ID · 0cf95c20-c2fe-45d5-99a6-5d73a87331ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 609238
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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.