FDA Inspection
Maimonides Medical Center IRBMaimonides Medical Center IRB – FDA Inspection, Sep 16, 2016
Record Details
This FDA Inspection record concerns Maimonides Medical Center IRB, with an inspection on September 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 16, 2016
- Product Type
- Devices
View Company Profile
ID · c8e22056-e36e-4a57-850c-556789f9e29e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986828
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Maimonides Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2024 | VAI | Center for Drug Evaluation and Research | Project Evaluation: Devices |
| May 5, 2011 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for Maimonides Medical Center IRB
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.