FDA Inspection
St Vincent HealthSt Vincent Health – FDA Inspection, Oct 22, 2009
Record Details
This FDA Inspection record concerns St Vincent Health, with an inspection on October 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St Vincent Health
- Inspection Date
- October 22, 2009
- Product Type
- Devices
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ID · bca660b0-dc68-4eac-8bb1-c304d96e5d61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625446
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of St Vincent Health
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 26, 2013 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St Vincent Health
- FDA Inspection 1040748 - 2018-01-18
- FDA Inspection 845879 - 2013-08-26
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