FDA Inspection
Barnes-Jewish Hospital Blood BankBarnes-Jewish Hospital Blood Bank – FDA Inspection, Mar 15, 2011
Record Details
This FDA Inspection record concerns Barnes-Jewish Hospital Blood Bank, with an inspection on March 15, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 15, 2011
- Product Type
- Biologics
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ID · d736a6bd-0dad-4987-870f-d6d257897623
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715430
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 606.165(b)Distribution records - content
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(13)Procedures to relate blood from donor to final disposition
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| February 6, 2014 | 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 865778 - 2014-02-06
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