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1163359

Lilly del Caribe, Inc — FEI 2619243

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 25, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carolina, PR (United States)

Facility

Other inspections at this facility

  • 1300794 (VAI Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097298 (VAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069938 (VAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020761 (VAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927312 (NAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls