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1251186

L. Perrigo Company — FEI 1811666

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allegan, MI (United States)

Facility

Other inspections at this facility

  • 1221191 (NAI Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076466 (VAI Thu Jan 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906986 (NAI Thu Dec 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894507 (VAI Thu Sep 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854293 (VAI Thu Nov 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
149521 CFR 211.122(a)Written procedures describing in detail
192021 CFR 211.166(a)(3)Valid stability test methods
430221 CFR 211.56(b)Written sanitation procedures not followed