FDA Inspection
Evanston Hospital Blood BankEvanston Hospital Blood Bank – FDA Inspection, Aug 6, 2019
Record Details
This FDA Inspection record concerns Evanston Hospital Blood Bank, with an inspection on August 6, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ff5df701-5c26-4b65-a58c-c0d8438c98f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098763
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 | |
| 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 |
| June 26, 2012 | 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 1016698 - 2017-05-26
- FDA Inspection 1017838 - 2016-02-08
- FDA Inspection 867919 - 2014-02-28
- FDA Inspection 788914 - 2012-06-26
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