FDA Inspection
UPMC Horizon ShenangoUPMC Horizon Shenango – FDA Inspection, Oct 21, 2008
Record Details
This FDA Inspection record concerns UPMC Horizon Shenango, with an inspection on October 21, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- UPMC Horizon Shenango
- Inspection Date
- October 21, 2008
- Product Type
- Biologics
View Company Profile
ID · 77e808c8-a767-4dd2-85e1-04306e95beff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544969
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.204Record information inclusions
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
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 |
| July 7, 2010 | 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 668351 - 2010-07-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.