FDA Inspection
Ascension St. John Hospital IRBAscension St. John Hospital IRB – FDA Inspection, Mar 21, 2012
Record Details
This FDA Inspection record concerns Ascension St. John Hospital IRB, with an inspection on March 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 21, 2012
- Product Type
- Devices
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ID · abb50bdb-a269-482f-903d-6e895df6c044
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776083
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.7(d)Investigational device represented as safe and /or effective
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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Other FDA inspections of Ascension St. John Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2022 | NAI | Bioresearch Monitoring | |
| December 23, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ascension St. John Hospital IRB
- FDA Inspection 1178321 - 2022-08-12
- FDA Inspection 997372 - 2016-12-23
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