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FDA Inspection
•Rady Children's Hospital San Diego IRB•February 5, 2009

Rady Children's Hospital San Diego IRB – FDA Inspection, Feb 5, 2009

Record Details

This FDA Inspection record concerns Rady Children's Hospital San Diego IRB, with an inspection on February 5, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Rady Children's Hospital San Diego IRB
Inspection Date
February 5, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ae4b800b-58f4-4747-96a5-d2c238738c38

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
560477
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  3. 21 CFR 56.109(h)Children as subjects
  4. 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Rady Children's Hospital San Diego IRB

1
DateClassificationOfficeProject area
July 17, 2014VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Rady Children's Hospital San Diego IRB
  • FDA Inspection 888169 - 2014-07-17

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