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654888

Pharbest Pharmaceuticals, Inc. — FEI 3005382247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 30, 2010
Fiscal Year
2010
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))
  • 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))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
192721 CFR 211.166(b)Accelerated stability studies
194221 CFR 211.180(e)Records reviewed annually
200921 CFR 211.188Prepared for each batch, include complete information
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs