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1061913

Bausch & Lomb Incorporated — FEI 1000113778

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 10, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tampa, FL (United States)

Facility

Other inspections at this facility

  • 1218198 (NAI Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082137 (NAI Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015001 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967714 (NAI Thu Feb 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917087 (VAI Fri Mar 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202821 CFR 211.192Extent of discrepancy, failure investigations
203121 CFR 211.194(a)Complete test data included in records
360221 CFR 211.160(a)Deviations from laboratory control requirements
441321 CFR 211.194(a)(8)Second person sign off