BBS: 5th Consecutive Inspection without FDA FORM 483
Biotrial Bioanalytical Services (BBS) in Laval, Canada successfully underwent its fifth consecutive FDA inspection recently where no FDA Form 483 was issued. This once again demonstrates an exemplary track record since establishing the facility in 2013 and shows a promising and active 2020.
The unannounced inspection involved a thorough review of SOPs, study-related documents, data security, software validation as well as general facility documentation. The visit from the FDA validated the high quality work being done at BBS. We are extremely pleased to have such expertise and hard-work acknowledged at the highest level.
BBS offers bioanalytical services from discovery, though to all phases of early and late clinical development. The Montreal based team of experts specializes in assisting Sponsors to develop even the most challenging assays using LC-MS/MS through all stages of development.
To find out more and ask any questions, please get in touch via biotrial.com/contact-us
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