FDA Inspection
Dr. Ronald G. CrystalDr. Ronald G. Crystal – FDA Inspection, Oct 24, 2012
Record Details
This FDA Inspection record concerns Dr. Ronald G. Crystal, with an inspection on October 24, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Dr. Ronald G. Crystal
- Inspection Date
- October 24, 2012
- Product Type
- Biologics
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ID · 3fce3aac-c5bc-4555-983f-27ce5dbf1add
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804202
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.66Unanticipated problems
- 21 CFR 312.64(b)Safety reports
- 21 CFR 312.57(a)Records of receipt, shipment, disposition
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