FDA Inspection
Los Angeles County Department of Health Services IRBLos Angeles County Department of Health Services IRB – FDA Inspection, Aug 7, 2009
Record Details
This FDA Inspection record concerns Los Angeles County Department of Health Services IRB, with an inspection on August 7, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 7, 2009
- Product Type
- Biologics
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ID · 3d06ded6-bab2-4bdc-bbb5-92147fe99bad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603155
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(c)Method to keep members advised
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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