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977465

Thatcher Company, Inc. — FEI 1714750

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 10, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1283408 (NAI Wed Sep 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111900 (NAI Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067393 (VAI Tue Sep 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790878 (NAI Thu May 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 740198 (VAI Fri Aug 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
188521 CFR 211.165(b)Microbiological testing
354821 CFR 211.46(c)Air filtration system lacking in production area
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360921 CFR 211.160(b)(2)In-process sample representation/identification
430321 CFR 211.67(b)Written procedures fail to include