FDA Inspection
Southern IL Hosp. Services dba Memorial Hosp. Carbondale IRBSouthern IL Hosp. Services dba Memorial Hosp. Carbondale IRB – FDA Inspection, Feb 15, 2013
Record Details
This FDA Inspection record concerns Southern IL Hosp. Services dba Memorial Hosp. Carbondale IRB, with an inspection on February 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 15, 2013
- Product Type
- Drugs
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ID · e174568d-a816-41ee-9aa1-06df327eeb7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817951
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 50.52Factors required for approval
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
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Other FDA inspections of Southern IL Hosp. Services dba Memorial Hosp. Carbondale IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Southern IL Hosp. Services dba Memorial Hosp. Carbondale IRB
- FDA Inspection 1064574 - 2018-08-03
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