FDA Inspection
PeaceHealth LaboratoriesPeaceHealth Laboratories – FDA Inspection, Apr 30, 2013
Record Details
This FDA Inspection record concerns PeaceHealth Laboratories, with an inspection on April 30, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- PeaceHealth Laboratories
- Inspection Date
- April 30, 2013
- Product Type
- Biologics
View Company Profile
ID · c33646c4-855a-4787-97fe-0664c239eeb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838966
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
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 |
| July 21, 2011 | 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 735262 - 2011-07-21
- FDA Inspection 675472 - 2010-08-04
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