Inspection HISTORY

Date Event Date Event Date Event
Aug-2001FDA cGMP Inspection July-2011FDA cGMP Inspection Jan-2017FDA cGMP Inspection
May-2002FDA cGMP Inspection Mar-2012FDA cGMP Inspection Dec-2020DEA Inspection
Jan-2004FDA cGMP Inspection Nov-2012FDA cGMP Inspection Mar-2021NJ DOH Inspection
Mar-2005FDA cGMP Inspection Jan-2013DEA Inspection Dec-2021NJ DEP Inspection
Mar-2007FDA cGMP Inspection Mar-2014FDA cGMP Inspection Aug-2024FDA cGMP Inspection
July-2007US EPA Inspection July-2014DEA Inspection
Apr-2011NJ DEP Inspection Jan-2016NJ DOH Inspection

CLIENTS’ AUDITS

Date Event Date Event Date Event
Jun-2005UK client audit Jun-2018Italian client audit Jul-2021Italian client audit
Jul-2006US client audit Sep-2018Japanese client audit Dec-2022Canada client audit
Jul-2010UK client audit Dec-2018Chinese client audit Feb-2023UK client audit
Feb-2011US client audit Mar-2019US client audit Mar-2023US client audit
Jul-2011UK client audit Apr-2019US client audit Apr-2024US client audit
Dec-2011US client audit Apr-2019UK client audit Aug-2024Italian client audit
Dec-2017UK client audit Mar-2021US client audit Mar-2025UK client audit
Mar-2018US client audit Apr-2021US client audit

Quality

  • Comprehensive quality systems
  • Qualified personnel & continuous training
  • Qualification of vendors/suppliers
  • Change controllable documents and records
  • Document review & product release
  • Self-inspection and continuous improvement

Regulatory

  • Eleven FDA inspections completed since 2001
  • Five DMFs filed
  • US EPA and NJ DEP inspections
  • Multiple client audits