FDA Inspection
Baton Rouge General Medical Center IRBBaton Rouge General Medical Center IRB – FDA Inspection, Sep 14, 2023
Record Details
This FDA Inspection record concerns Baton Rouge General Medical Center IRB, with an inspection on September 14, 2023, covering biologics.
- Inspection Date
- September 14, 2023
- Product Type
- Biologics
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ID · a3d9f6b3-90e5-4b2f-825f-e81b0194e987
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217721
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.52Factors required for approval
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 50.52Factors required for approval
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of Baton Rouge General Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Baton Rouge General Medical Center IRB
- FDA Inspection 799242 - 2012-08-17
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