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1021532

Bayer HealthCare LLC — FEI 2510692

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Myerstown, PA (United States)

Facility

Other inspections at this facility

  • 1209567 (NAI Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199413 (NAI Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852054 (VAI Fri Oct 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 739275 (NAI Thu Jul 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 591232 (NAI Mon Jun 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records