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746226

Viatris Pharmaceuticals LLC — FEI 2627208

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 23, 2011
Fiscal Year
2011
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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
360721 CFR 211.160(b)(2)Acceptance of in-process materials
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.