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1153105

Grace Analytical Lab Inc — FEI 3007291509

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 29, 2021
Fiscal Year
2021
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Berkeley, IL (United States)

Facility

Other inspections at this facility

  • 1092034 (OAI Thu May 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007614 (OAI Mon Jan 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870581 (NAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 750556 (NAI Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681349 (VAI Thu Sep 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
113621 CFR 211.25(c)Inadequate number of personnel
116821 CFR 211.34Consultant Records
126321 CFR 211.68(b)Computer control of master formula records
191421 CFR 211.166(a)Lack of written stability program
203121 CFR 211.194(a)Complete test data included in records
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly
900121 CFR 211.22(a)Lack of quality control unit