FDA Inspection
Memorial Hospital Of South Bend, IRBFDA Inspection 779831 - Memorial Hospital Of South Bend, IRB - April 23, 2012
Record Details
This FDA Inspection record concerns Memorial Hospital Of South Bend, IRB, with an inspection on April 23, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 23, 2012
- Product Type
- Drugs
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ID · 9bc493bd-24bc-4c08-9197-cf3be20da72c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 779831
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Memorial Hospital Of South Bend, IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Memorial Hospital Of South Bend, IRB
- FDA Inspection 854297 - 2013-11-06
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