FDA Inspection
Jeffrey A. Kalish, MDJeffrey A. Kalish, MD – FDA Inspection, Dec 23, 2016
Record Details
This FDA Inspection record concerns Jeffrey A. Kalish, MD, with an inspection on December 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c1eff67e-2161-4f93-8037-3056e5ddcfc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999373
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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.