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1230040

Belleview 402 LLC — FEI 3005350897

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 15, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brooksville, FL (United States)

Facility

Other inspections at this facility

  • 1149291 (OAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079690 (OAI Fri Feb 15 2019 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
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
356721 CFR 211.84(d)(2)Component identification test
360321 CFR 211.160(b)Scientifically sound laboratory controls