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1095135

Sunrider Manufacturing L.P. — FEI 1000125398

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 3, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Midlothian, TX (United States)

Facility

Other inspections at this facility

  • 1261189 (VAI Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886346 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 766418 (NAI Wed Feb 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 682274 (NAI Mon Sep 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
191221 CFR 211.166(a)Written program not followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed