FDA Inspection
BURKE PHARMACEUTICAL RESEARCHBURKE PHARMACEUTICAL RESEARCH – FDA Inspection, Jul 24, 2009
Record Details
This FDA Inspection record concerns BURKE PHARMACEUTICAL RESEARCH, with an inspection on July 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 24, 2009
- Product Type
- Drugs
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ID · aa387777-0ab1-44dc-8210-2cf6ad3ad1d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 602255
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.55(f)Documentation of permission by parents or guardian
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Other FDA inspections of BURKE PHARMACEUTICAL RESEARCH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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