FDA Inspection
PeaceHealth LaboratoriesPeaceHealth Laboratories – FDA Inspection, Sep 22, 2009
Record Details
This FDA Inspection record concerns PeaceHealth Laboratories, with an inspection on September 22, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- PeaceHealth Laboratories
- Inspection Date
- September 22, 2009
- Product Type
- Biologics
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ID · 214757ff-d378-40c5-a637-75cc44136c80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614228
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.4(f)Arm preparation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of PeaceHealth Laboratories
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 1, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for PeaceHealth Laboratories
- FDA Inspection 779418 - 2012-04-10
- FDA Inspection 735261 - 2011-07-20
- FDA Inspection 681047 - 2010-09-01
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