FDA Inspection
LifeStream Blood BankLifeStream Blood Bank – FDA Inspection, Sep 24, 2010
Record Details
This FDA Inspection record concerns LifeStream Blood Bank, with an inspection on September 24, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- LifeStream Blood Bank
- Inspection Date
- September 24, 2010
- Product Type
- Biologics
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ID · 6b2b9d18-7e04-4e9b-88bd-617a1d565982
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682680
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of LifeStream Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 11, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 11, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 7, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 9, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for LifeStream Blood Bank
- FDA Inspection 1225340 - 2023-12-08
- FDA Inspection 1067660 - 2018-09-11
- FDA Inspection 981332 - 2016-08-11
- FDA Inspection 835363 - 2013-06-07
- FDA Inspection 773846 - 2012-03-09
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