FDA Inspection
Ascension Via Christi Hospitals Wichita IncAscension Via Christi Hospitals Wichita Inc – FDA Inspection, Feb 26, 2014
Record Details
This FDA Inspection record concerns Ascension Via Christi Hospitals Wichita Inc, with an inspection on February 26, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 26, 2014
- Product Type
- Biologics
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ID · e2a99a9e-a751-4c2b-9759-f6494c379dd1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 864800
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.165(a)Distribution and receipt - recalls
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Ascension Via Christi Hospitals Wichita Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 15, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 16, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Ascension Via Christi Hospitals Wichita Inc
- FDA Inspection 1229777 - 2024-02-06
- FDA Inspection 1110377 - 2019-11-18
- FDA Inspection 1037712 - 2017-11-15
- FDA Inspection 955048 - 2015-12-16
- FDA Inspection 776390 - 2012-04-11
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