FDA Inspection
Northwestern Memorial Hospital Blood BankNorthwestern Memorial Hospital Blood Bank – FDA Inspection, Mar 17, 2010
Record Details
This FDA Inspection record concerns Northwestern Memorial Hospital Blood Bank, with an inspection on March 17, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 17, 2010
- Product Type
- Biologics
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ID · 7250f69b-08b1-4315-9abb-01622a1b65b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654274
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Northwestern Memorial Hospital Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 2, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Northwestern Memorial Hospital Blood Bank
- FDA Inspection 1250714 - 2024-09-17
- FDA Inspection 1071028 - 2018-09-26
- FDA Inspection 985178 - 2016-04-19
- FDA Inspection 891830 - 2014-08-20
- FDA Inspection 775243 - 2012-04-02
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