More Great News from the Tox Group; another clean FDA inspection
The FDA completed an audit of the BASi Evansville Toxicology facility in March 2010. This occurs about every 2 years and once again, there were no findings to report. The inspector spoke highly of the BASi staff's ability to answer questions and their obvious skill in their various functions. Up-to-date training records, clear protocols, well documented SOPs, current QC/QA documents as well as final reports that meet and exceed the FDA requirements for a client’s IND submissions are the BASi norm.
FDA findings are recorded as Form 483s. These records are available to the public through the "Freedom of Information Act" and are widely distributed through the industry. In the history of the BASi Toxicology, we have received only one Form 483. That was in 1993 for a minor computer validation issue.
Regulatory excellence is important to your success. Work with a team that you can trust. Contact BASi or call your local BASi representative.
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