FDA Inspection
Evanston Hospital Blood BankEvanston Hospital Blood Bank – FDA Inspection, Aug 13, 2010
Record Details
This FDA Inspection record concerns Evanston Hospital Blood Bank, with an inspection on August 13, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Evanston Hospital Blood Bank
- Inspection Date
- August 13, 2010
- Product Type
- Biologics
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ID · ff1faa87-996c-4392-b35e-204a6ac63198
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675977
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Evanston Hospital Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | Not classified | Chicago District Office | |
| August 6, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 28, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Evanston Hospital Blood Bank
- FDA Inspection 1249555 - 2024-09-11
- FDA Inspection 1098763 - 2019-08-06
- FDA Inspection 1016698 - 2017-05-26
- FDA Inspection 1017838 - 2016-02-08
- FDA Inspection 867919 - 2014-02-28
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