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998830

Belleview 402 LLC — FEI 3005350897

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 25, 2017
Fiscal Year
2017
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))
  • 1079690 (OAI Fri Feb 15 2019 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
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188521 CFR 211.165(b)Microbiological testing
192621 CFR 211.166(b)Adequate number of batches on stability
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls
900121 CFR 211.22(a)Lack of quality control unit