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FDA Inspection
•Good Samaritan Medical Center IRB•September 11, 2009

Good Samaritan Medical Center IRB – FDA Inspection, Sep 11, 2009

Record Details

This FDA Inspection record concerns Good Samaritan Medical Center IRB, with an inspection on September 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Good Samaritan Medical Center IRB
Inspection Date
September 11, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 47bd801a-f23b-4034-9b17-dee2818847a0

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
619927
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 56.108(c)Members present for review
  2. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  3. 21 CFR 56.115(a)(3)Records of continuing review
  4. 21 CFR 56.108(a)(1)Initial and continuing reviews

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