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1278978

Pharbest Pharmaceuticals, Inc. — FEI 3005382247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Facility

Other inspections at this facility

  • 1190336 (VAI Thu Nov 10 2022 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
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
195721 CFR 211.180(e)(2)Review of problem drugs
361321 CFR 211.160(b)(4)Establishment of calibration procedures
363221 CFR 211.170(b)Annual visual exams of drug products
430421 CFR 211.68(b)Written record not kept of program and validation data