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704851

Bausch & Lomb Incorporated — FEI 1032500

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Greenville, SC (United States)

Facility

Other inspections at this facility

  • 1250877 (OAI Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073462 (NAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031429 (NAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988726 (VAI Wed Oct 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911396 (NAI Thu Jan 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
191221 CFR 211.166(a)Written program not followed
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures