FDA Inspection
Judith L. Kirstein, MDJudith L. Kirstein, MD – FDA Inspection, Aug 19, 2009
Record Details
This FDA Inspection record concerns Judith L. Kirstein, MD, with an inspection on August 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Judith L. Kirstein, MD
- Inspection Date
- August 19, 2009
- Product Type
- Biologics
View Company Profile
ID · cc64ebee-4944-473e-bdcc-83addccee8eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607784
- FDA center
- Biologics
- 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 Judith L. Kirstein, MD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2023 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| May 11, 2018 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| October 3, 2014 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for Judith L. Kirstein, MD
- FDA Inspection 1205612 - 2023-05-12
- FDA Inspection 1055847 - 2018-05-11
- FDA Inspection 900423 - 2014-10-03
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.