FDA Inspection
Stormont Vail HealthCare Inc.Stormont Vail HealthCare Inc. – FDA Inspection, Jun 4, 2010
Record Details
This FDA Inspection record concerns Stormont Vail HealthCare Inc., with an inspection on June 4, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 4, 2010
- Product Type
- Biologics
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ID · 0b17ec29-3cec-49a5-86e3-c90fde84830c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664590
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Stormont Vail HealthCare Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | Not classified | Kansas City District Office | |
| April 24, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 7, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 6, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 29, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stormont Vail HealthCare Inc.
- FDA Inspection 1256293 - 2024-11-07
- FDA Inspection 1087732 - 2019-04-24
- FDA Inspection 1005799 - 2017-03-07
- FDA Inspection 921704 - 2015-04-06
- FDA Inspection 810326 - 2012-11-29
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