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
- 2011 – GMP
- 2009 – Bioanalytical
- 2006 – Bioanalytical (January and December)
- 2005 – Bioanalytical
- 2004 – Bioanalytical
- 2003 – BE/Bioanalytical
- 2000 – GMP
- Current Permits/Certifications
Evansville, Indiana
- FDA Inspection History
- 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
McMinnville, Oregon
- FDA Inspection History
- 2011 – Bioanalytical
- 2007 – Bioanalytical
- 2004 – Bioanalytical
- Current Permits/Certifications
- CDC
- USDA
- DEA
- Fish & Wildlife
Warwickshire, UK
The FDA and the Medicines and Healthcare Products Agency (MHRA) both review operations in Warwickshire, UK. We have been a long-standing member of the agency’s GLP compliance program. BASi is subject to biennial combined GLP/GCP inspections, most recently in July 2011. The facility has also undergone successful FDA inspections on two occasions, covering both clinical and non-clinical studies.
Our quality and managerial staff is readily available to discuss any findings and their corrections with our clients during client audits. Contact us with any questions.
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