FDA Inspection
Michael Dean Berger MDMichael Dean Berger MD – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Michael Dean Berger MD, with an inspection on June 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Michael Dean Berger MD
- Inspection Date
- June 10, 2010
- Product Type
- Biologics
View Company Profile
ID · 34988447-6bb4-4b79-9cd4-9891809fc953
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 668088
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 312.66Changes in research
- 21 CFR 50.20Understandable language
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