752513

Jerome Stevens Pharmaceuticals, Inc. — FEI 2431950

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 22, 2011
Fiscal Year
2012
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Bohemia, NY (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
433021 CFR 211.130(e)Packaging line inspection documentation
890921 CFR 314.81(b)(2)(ii)Distribution data
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications