566300

Airgas USA LLC — FEI 3017102

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 2, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kent, WA (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
126121 CFR 211.68(a)Written calibration / inspection records not kept
187621 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
200821 CFR 211.186(a)Written procedures followed
202621 CFR 211.192Quality control unit review of records
202821 CFR 211.192Extent of discrepancy, failure investigations
357021 CFR 211.100(a)Approval and review of procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361521 CFR 211.160(b)(4)Test devices not meeting specifications