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1190336

Pharbest Pharmaceuticals, Inc. — FEI 3005382247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Facility

Other inspections at this facility

  • 1278978 (VAI Mon Sep 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155859 (NAI Wed Nov 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048617 (VAI Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930773 (VAI Mon Jun 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888588 (VAI Fri Jul 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
192621 CFR 211.166(b)Adequate number of batches on stability
203421 CFR 211.194(d)Laboratory equipment calibration records
430321 CFR 211.67(b)Written procedures fail to include
440221 CFR 211.192Written record of investigation incomplete