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1149250

RNV LLC — FEI 3026274805

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 20, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami Lakes, FL (United States)

Facility

Other inspections at this facility

  • 1289892 (VAI Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092666 (OAI Mon Jun 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948189 (NAI Fri Nov 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819846 (VAI Mon Feb 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
440621 CFR 211.194(a)(2)Suitability of testing methods verified