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844978

Viatris Pharmaceuticals LLC — FEI 2627208

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 20, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Barceloneta, PR (United States)

Facility

Other inspections at this facility

  • 1273532 (NAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115559 (VAI Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046857 (VAI Wed Mar 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002319 (NAI Thu Dec 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935961 (VAI Thu Jul 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122721 CFR 211.67(c)Cleaning/maintenance records not kept
127021 CFR 211.68(b)input/output verification
180921 CFR 211.160(a)Following/documenting laboratory controls
192021 CFR 211.166(a)(3)Valid stability test methods
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
360321 CFR 211.160(b)Scientifically sound laboratory controls
362921 CFR 211.170(b)Reserve samples identified, representative, stored
430321 CFR 211.67(b)Written procedures fail to include
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440221 CFR 211.192Written record of investigation incomplete
440421 CFR 211.194(a)(1)Sample identification and other information
440921 CFR 211.194(a)(4)Data secured in course of each test
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications