BioPharma Services Bioanalytical Laboratory passes FDA inspection with flying colours

Following the recent inspection of the clinical site in St. Louis, Missouri (and previous to that, the Toronto clinic site in May 2022), FDA Inspectors came on site to inspect the BioPharma Services’ bioanalytical laboratory in Toronto, Canada.

During the week of October 24, 2022, five studies were audited, including validations. There were no observations, therefore zero 483 was issued. We are very proud to say that this was a clean sweep for all BioPharma Services locations!

Vaideki Dharmaratnam, Associate Director Quality Assurance (Lab) noted “The inspection went very smoothly with a lot of very good discussions. The Bioanalytical Laboratory was without a doubt ’inspection ready’. The inspection concluded one day early, which speaks volumes to the quality of the BioPharma Lab data”.

Dr. Nicola Hughes, Vice President of Bioanalytical Laboratory Operations commented, “BioPharma’s rigorous SOPs and procedures translate into trial confidence for our clients who can rest assured that every facet of their study is executed to an exceptionally high standard. With capacity for up to 20k samples per month, passing batch rates typically in excess of 96.5% and reproducibility rates of 99%, BioPharma’s lab operates at world-class levels.

Review BioPharma’s Full Regulatory History Here.

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