FDA Inspection
Barnes-Jewish Hospital Blood BankBarnes-Jewish Hospital Blood Bank – FDA Inspection, Feb 6, 2014
Record Details
This FDA Inspection record concerns Barnes-Jewish Hospital Blood Bank, with an inspection on February 6, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 6, 2014
- Product Type
- Biologics
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ID · 77127281-a723-410d-8749-fd1b598e264a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865778
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.171Biological product deviation report
- 21 CFR 640.25(b)(4)Corrective action
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(13)Procedures to relate blood from donor to final disposition
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Other FDA inspections of Barnes-Jewish Hospital Blood Bank
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 12, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 26, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Barnes-Jewish Hospital Blood Bank
- FDA Inspection 1240233 - 2024-05-16
- FDA Inspection 1122248 - 2020-03-05
- FDA Inspection 1049735 - 2018-04-12
- FDA Inspection 967700 - 2016-04-26
- FDA Inspection 785852 - 2012-06-06
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