FDA Inspection
St Luke's Hospital Blood BankSt Luke's Hospital Blood Bank – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns St Luke's Hospital Blood Bank, with an inspection on September 24, 2026, issued by the Kansas City District Office, covering biologics.
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ID · 53f75707-3131-4aa8-a1b2-9c5063f2d85e
Inspection Facts
- Inspection number
- 1337874
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.160(b)Required records
- 21 CFR 606.171Biological product deviation report
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Other FDA inspections of St Luke's Hospital Blood Bank
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 15, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St Luke's Hospital Blood Bank
- FDA Inspection 1223636 - 2023-11-16
- FDA Inspection 1074145 - 2018-12-04
- FDA Inspection 993223 - 2016-11-15
- FDA Inspection 915675 - 2015-02-19
- FDA Inspection 822432 - 2013-03-13
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