1025975

Anika Therapeutics, Inc. — FEI 3007093114

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Bedford, MA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
143021 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
154021 CFR 211.125(a)Strict control not exercised over labeling issued
202721 CFR 211.192Investigations of discrepancies, failures
356621 CFR 211.84(c)(4)Composite sample top/middle/bottom