FDA Inspection
Ledesma, Gilbert, M.D.Ledesma, Gilbert, M.D. – FDA Inspection, Sep 28, 2009
Record Details
This FDA Inspection record concerns Ledesma, Gilbert, M.D., with an inspection on September 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ledesma, Gilbert, M.D.
- Inspection Date
- September 28, 2009
- Product Type
- Drugs
View Company Profile
ID · 81795f59-484d-4e11-96c1-33ef5705ccd3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 618035
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ledesma, Gilbert, M.D.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 11, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ledesma, Gilbert, M.D.
- FDA Inspection 885148 - 2014-06-19
- FDA Inspection 709412 - 2011-02-11
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.