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1120499

Llorens Pharmaceuticals International Division, Inc. — FEI 3008468946

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
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))
  • 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))
  • 783137 (NAI Tue May 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
110521 CFR 211.22(d)Procedures not in writing, fully followed
201721 CFR 211.188(b)(5)In-Process and Laboratory Control Results
440621 CFR 211.194(a)(2)Suitability of testing methods verified