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707778

Viatris Pharmaceuticals LLC — FEI 2623619

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 26, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vega Baja, PR (United States)

Facility

Other inspections at this facility

  • 1162864 (VAI Thu Feb 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038692 (VAI Fri Jan 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990477 (VAI Tue Jul 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933988 (VAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871101 (VAI Tue Mar 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
188321 CFR 211.165(a)Testing and release for distribution
200921 CFR 211.188Prepared for each batch, include complete information
202821 CFR 211.192Extent of discrepancy, failure investigations
203121 CFR 211.194(a)Complete test data included in records
203421 CFR 211.194(d)Laboratory equipment calibration records
241921 CFR 211.198(a)Complaint Handling Procedure
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430621 CFR 211.80(a)Written Procedures Not Followed