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678287

Llorens Pharmaceuticals International Division, Inc. — FEI 3008468946

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1229574 (VAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1258728 (VAI Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120499 (VAI Wed Mar 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100710 (VAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979515 (VAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
208921 CFR 211.208No records maintained
241921 CFR 211.198(a)Complaint Handling Procedure
256721 CFR 211.198(a)Adverse Drug Experience
363921 CFR 211.204Returned drug procedures in writing and followed
433621 CFR 211.150Written distribution procedure
900121 CFR 211.22(a)Lack of quality control unit