FDA Inspection
West Michigan Cancer Center IRBWest Michigan Cancer Center IRB – FDA Inspection, Feb 11, 2011
Record Details
This FDA Inspection record concerns West Michigan Cancer Center IRB, with an inspection on February 11, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 11, 2011
- Product Type
- Biologics
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ID · ea064c29-fd67-46fc-b2bb-d05088a9b107
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712278
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 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 West Michigan Cancer Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for West Michigan Cancer Center IRB
- FDA Inspection 1035704 - 2017-11-02
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