840156

Formulation Technology LLC — FEI 2937960

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oakdale, CA (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
135821 CFR 211.100(b)SOPs not followed / documented
203121 CFR 211.194(a)Complete test data included in records
441321 CFR 211.194(a)(8)Second person sign off