BioPharma Services, Inc. successfully completes three FDA inspections with zero Form 483’s.
BioPharma Services, Inc. announced that it has successfully completed three inspections this month by the U.S. FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, MO. Over the course of two weeks, the back-to-back inspections focused on a total of nine studies, including four bioanalytical validations that were conducted in support of ANDA and NDA filings to the FDA. All three inspections concluded without a 483 Form being issued as BioPharma continues to build on its regulatory track history with zero observations.
BioPharma’s U.S.-based clinical facility in Columbia, MO, underwent two sequential FDA inspections. Since its opening in 2014, the clinical site has completed a number of pivotal programs to support drug submissions to the FDA and is poised to undergo a clinical expansion to 120-beds this summer.
The three inspections were hosted and led by BioPharma’s senior management team, including Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs; Louis Co, VP of Global Clinical Operations, and Dr. Nicki Hughes, VP of Bioanalytical Operations.
(Source: Business Wire)