969790

Denison Pharmaceuticals, LLC — FEI 1210580

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2016
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Lincoln, RI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
126321 CFR 211.68(b)Computer control of master formula records
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair
440921 CFR 211.194(a)(4)Data secured in course of each test