FDA Inspection
St Louis Children's HospitalSt Louis Children's Hospital – FDA Inspection, Nov 20, 2025
Record Details
This FDA Inspection record concerns St Louis Children's Hospital, with an inspection on November 20, 2025, issued by the Kansas City District Office, covering biologics.
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ID · 33d726d0-fac9-4ede-8055-e942e21cd0b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1292148
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St Louis Children's Hospital
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 28, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 26, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 19, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St Louis Children's Hospital
- FDA Inspection 1191063 - 2022-11-10
- FDA Inspection 1063936 - 2018-08-28
- FDA Inspection 910898 - 2015-01-26
- FDA Inspection 810091 - 2012-12-10
- FDA Inspection 707085 - 2011-01-19
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