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Lilly del Caribe, Inc — FEI 2619243

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 22, 2013
Fiscal Year
2013
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))
  • 1163359 (VAI Fri Feb 25 2022 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))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
1774921 CFR 212.30(a)Prevention of contamination
202821 CFR 211.192Extent of discrepancy, failure investigations
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration