FDA Inspection
VA Puget Sound Health Care System, American Lake DivisionVA Puget Sound Health Care System, American Lake Division – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns VA Puget Sound Health Care System, American Lake Division, with an inspection on April 12, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 12, 2012
- Product Type
- Biologics
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ID · 23486ff1-1c39-4fe7-a696-0b5882d16719
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780586
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 600.12(a)Maintenance - completeness
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of VA Puget Sound Health Care System, American Lake Division
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA Puget Sound Health Care System, American Lake Division
- FDA Inspection 865025 - 2014-02-06
- FDA Inspection 682952 - 2010-09-28
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