FDA Inspection
PeaceHealth LaboratoriesPeaceHealth Laboratories – FDA Inspection, Jul 21, 2011
Record Details
This FDA Inspection record concerns PeaceHealth Laboratories, with an inspection on July 21, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- PeaceHealth Laboratories
- Inspection Date
- July 21, 2011
- Product Type
- Biologics
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ID · b7f12732-245f-4cfd-b365-1eee02398ea0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735262
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 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 |
|---|---|---|---|
| February 18, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 30, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 4, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for PeaceHealth Laboratories
- FDA Inspection 917341 - 2015-02-18
- FDA Inspection 838966 - 2013-04-30
- FDA Inspection 675472 - 2010-08-04
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