BioPharma Services Inc. recently passed three Food and Drug Administration inspections without a single Form 483 being issued.
The company’s U.S.-based clinical facility in Columbia, Missouri was reviewed by two sequential FDA inspections and the has completed a number of clinical trials since it opened in 2014. Form 483 is a form used by the FDA to document inspector observations as part of any complaint of non-compliance. For BioPharma Services, Inc. the lack of any 483 forms means that all of its operations were in strict compliance with government regulations.
“I am proud of both our teams in Canada and the US for maintaining the highest quality standards in delivering outstanding service to our clients," BioPharma’s Vice President of Global Clinical Operations Louis Co said in a statement. "The dedication of our teams to provide excellent quality and timely service to our clients sets us apart."
BioPharma Services is a contract research organization that specializes in conducting clinical trials and bioequivalence trials for pharmaceutical companies throughout the world. The company has clinical facilities in Canada and the United States that can accommodate 250 patients.
The company is headquartered in Toronto.