769943

Bayscience Formulators, LLC — FEI 3006210508

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 29, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dudley, MA (United States)

Citations

IDCFRDescription
154021 CFR 211.125(a)Strict control not exercised over labeling issued
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
430321 CFR 211.67(b)Written procedures fail to include
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies