FDA Inspection
Jonathan Bernstein, M.d.Jonathan Bernstein, M.d. – FDA Inspection, Mar 5, 2010
Record Details
This FDA Inspection record concerns Jonathan Bernstein, M.d., with an inspection on March 5, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Jonathan Bernstein, M.d.
- Inspection Date
- March 5, 2010
- Product Type
- Biologics
View Company Profile
ID · 9e5ee24d-a236-4f39-b843-0fe080601454
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645268
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.20Circumstances of obtaining consent
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