1014373

Uptite Company, Inc. — FEI 1219320

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Haverhill, MA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
194221 CFR 211.180(e)Records reviewed annually
201521 CFR 211.188(b)(3)Identification of Components and In-Process Materials
359221 CFR 211.110(c)In-process materials characteristics testing