Regulatory Compliance & Quality Assurance

Regulatory excellence is important to your success. BASi is a team you can trust.

BASi has an outstanding regulatory record. You will be more confident in meeting your targets and having a successful review and audit of your data by working with our experienced scientific team.

All of our facilities are inspected by the U.S Food and Drug Administration (FDA). Unannounced inspections have always resulted in either no findings or have required voluntary actions for correction. Those steps are documented in a form 483. To date, all of BASi’s responses to 483s have been accepted by the FDA, resulting in no further action.

West Lafayette, Indiana

• FDA Inspection History
  • 2012 – Bioanalytical
  • 2012 – GMP
  • 2011 – Bioanalytical
  • 2011 – GMP
  • 2009 – Bioanalytical
  • 2006 – Bioanalytical (January and December)
  • 2005 – Bioanalytical
  • 2004 – Bioanalytical
  • 2003 – BE/Bioanalytical
  • 2000 – GMP
• Current Permits/Certifications
  • DEA
  • USDA
  • CDC
  • U.S. Fish and Wildlife

Evansville, Indiana

• FDA Inspection History
  • 2012 GLP inspection
  • 2010 GLP inspection
  • 2008 GLP inspection
  • 2005 GLP inspection
  • No FDA 483 observations since 1993
• Current Licenses/Accreditations
  • AAALAC (Association for Assessment & Accreditation of Laboratory
    Animal Care International)
  • USDA
  • DEA