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1079690

Belleview 402 LLC — FEI 3005350897

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 15, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brooksville, FL (United States)

Facility

Other inspections at this facility

  • 1230040 (OAI Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149291 (OAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998830 (OAI Wed Jan 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874864 (VAI Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874869 (VAI Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
188521 CFR 211.165(b)Microbiological testing
192621 CFR 211.166(b)Adequate number of batches on stability
360321 CFR 211.160(b)Scientifically sound laboratory controls