FDA Inspection
St. Charles Medical CenterSt. Charles Medical Center – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns St. Charles Medical Center, with an inspection on April 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Farhana Khan (FDA Associated Person)
- Lauren E. Swantko (Issuing Officer)
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ID · af4af3df-aecf-4fc8-a1df-edfad3e33389
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017405
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 56.110(b)(2)Minor changes
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Other FDA inspections of St. Charles Medical Center
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St. Charles Medical Center
- FDA Inspection 650621 - 2010-03-17
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