FDA Inspection
University of Massachusetts Chan Medical School IRBUniversity of Massachusetts Chan Medical School IRB – FDA Inspection, Sep 22, 2010
Record Details
This FDA Inspection record concerns University of Massachusetts Chan Medical School IRB, with an inspection on September 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 22, 2010
- Product Type
- Biologics
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ID · 16a9bf0c-f6d7-40c2-a91e-a07d89fc2f98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682438
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of University of Massachusetts Chan Medical School IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2023 | Not classified | New England District Office | |
| January 28, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 4, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for University of Massachusetts Chan Medical School IRB
- FDA Inspection 1224376 - 2023-11-07
- FDA Inspection 959087 - 2016-01-28
- FDA Inspection 632287 - 2009-12-04
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