FDA Inspection
Robert Wood Johnson U Hosp @ Hamilton IRBRobert Wood Johnson U Hosp @ Hamilton IRB – FDA Inspection, Dec 22, 2021
Record Details
This FDA Inspection record concerns Robert Wood Johnson U Hosp @ Hamilton IRB, with an inspection on December 22, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 22, 2021
- Product Type
- Drugs
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ID · 8521a818-ae42-4a4a-bf3c-c0a85ae4ac3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1159429
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.106(e)Changes in contact or chairperson information
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