FDA Inspection
University of Massachusetts Chan Medical School IRBUniversity of Massachusetts Chan Medical School IRB – FDA Inspection, Dec 4, 2009
Record Details
This FDA Inspection record concerns University of Massachusetts Chan Medical School IRB, with an inspection on December 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 4, 2009
- Product Type
- Devices
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ID · d7f242fe-8989-410d-bc5f-2e10b770c440
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632287
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 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 |
| September 22, 2010 | VAI | Center for Biologics Evaluation and Research | 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 682438 - 2010-09-22
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