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874864

Belleview 402 LLC — FEI 3005350897

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 1, 2014
Fiscal Year
2014
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))
  • 998830 (OAI Wed Jan 25 2017 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
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
192621 CFR 211.166(b)Adequate number of batches on stability
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
363921 CFR 211.204Returned drug procedures in writing and followed