FDA Inspection
UPMC Horizon ShenangoUPMC Horizon Shenango – FDA Inspection, Jul 7, 2010
Record Details
This FDA Inspection record concerns UPMC Horizon Shenango, with an inspection on July 7, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- UPMC Horizon Shenango
- Inspection Date
- July 7, 2010
- Product Type
- Biologics
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ID · 21cb0394-a515-48bf-a99c-4e77d64d90fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 668351
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65Safe, sanitary, orderly storage
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of UPMC Horizon Shenango
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 21, 2008 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UPMC Horizon Shenango
- FDA Inspection 764679 - 2012-01-26
- FDA Inspection 544969 - 2008-10-21
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