602971

Reese Pharmaceutical Company — FEI 1518939

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
154021 CFR 211.125(a)Strict control not exercised over labeling issued
362921 CFR 211.170(b)Reserve samples identified, representative, stored