FDA Inspection
Community Health Network IRBCommunity Health Network IRB – FDA Inspection, Aug 29, 2012
Record Details
This FDA Inspection record concerns Community Health Network IRB, with an inspection on August 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Community Health Network IRB
- Inspection Date
- August 29, 2012
- Product Type
- Devices
View Company Profile
ID · 77fe34b6-d7ba-4cdc-a396-6b216a818ec5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797623
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Community Health Network IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | Not classified | Detroit District Office | |
| May 31, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 14, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Community Health Network IRB
- FDA Inspection 1272467 - 2025-06-12
- FDA Inspection 1015479 - 2017-05-31
- FDA Inspection 980791 - 2016-04-14
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