Compliance

Purisys has a history of proactively partnering with regulators to maintain the highest level of trust and to anticipate changes in the regulations, standards, and public expectations.

FDA Inspections

  • 2005 – Zero 483 findings
  • 2006 – Zero 483 findings
  • 2009 – Zero 483 findings
  • 2011 – Zero 483 findings
  • 2014 – Zero 483 findings
  • 2017 – Zero 483 findings

Additional Health Authority Inspections

  • 2013 – COFEPRIS (Mexico)
  • 2012 – Korea FDA

DEA Inspections
Strong proactive relationship with Atlanta and Washington offices. No findings in last inspections:

  • 2017 – 5 visits by DEA
  • 2018 – 3 visits by DEA
  • 2019 – 3 visits by DEA
  • 2020 – 2 visits by DEA (license approval)