FDA Inspection
Spectrum Health Institutional Review BoardSpectrum Health Institutional Review Board – FDA Inspection, Sep 17, 2014
Record Details
This FDA Inspection record concerns Spectrum Health Institutional Review Board, with an inspection on September 17, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 17, 2014
- Product Type
- Biologics
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ID · c424d4ab-9407-436a-8f51-568342f3e85e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897010
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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Other FDA inspections of Spectrum Health Institutional Review Board
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 9, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Spectrum Health Institutional Review Board
- FDA Inspection 1044859 - 2018-03-05
- FDA Inspection 628536 - 2009-11-09
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