984437

Aaron Thomas Company Inc — FEI 2050161

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 8, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Garden Grove, CA (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
357021 CFR 211.100(a)Approval and review of procedures
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
437821 CFR 211.188(b)(2)Identity of major equipment and lines used