FDA Inspection
Brian Berman MDBrian Berman MD – FDA Inspection, Aug 24, 2009
Record Details
This FDA Inspection record concerns Brian Berman MD, with an inspection on August 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Brian Berman MD
- Inspection Date
- August 24, 2009
- Product Type
- Drugs
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ID · 9e96adf7-09c8-4922-8d82-dc5735ad3f5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605966
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.50Ensuring compliance with plan and protocol
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.62(a)Accountability records
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