613182

Uptite Company, Inc. — FEI 1219320

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2009
Fiscal Year
2009
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Haverhill, MA (United States)

Citations

IDCFRDescription
122721 CFR 211.67(c)Cleaning/maintenance records not kept
139521 CFR 211.103Actual vs. theoretical yields not determined
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
355721 CFR 211.52Washing and toilet facilities are deficient
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
430621 CFR 211.80(a)Written Procedures Not Followed
437721 CFR 211.188(b)(3)Identification of each component or in-process material
900121 CFR 211.22(a)Lack of quality control unit