BioPharma Services Secures Successful FDA Inspection of St. Louis Clinical Facility
BioPharma Services is pleased to share that our US clinical site located near St. Louis, Missouri was the subject of an unannounced FDA inspection from October 4-6, 2022. Though BioPharma has a long successful FDA regulatory history in the US at the previous Columbia, Missouri site, this is the first inspection of the St. Louis clinical site, which opened in 2020.
Inspectors found zero data discrepancies between the source and the data submitted to the FDA, with no issues or concerns to report and no discussion points to review. As a result, there was no Form 483 issued. Considering this was an unannounced FDA Inspection, it speaks volumes as to the inspection readiness of the St. Louis, MO site.
Holly McAfee, Associate Director of Quality Assurance, who was on hand to host the inspection team noted, “The exceptional US team were able to easily demonstrate the quality of service offered by the St. Louis site. The clinic was truly ‘FDA-ready’ with no issues or concerns identified by inspectors.”.
Anna Taylor, Managing Director of BioPharma Services, commented, “The Human Abuse Liability and Phase 1 capabilities of our US site have been further cemented with this audit. Our teams in both Toronto, Canada and USA work tirelessly to execute our clients’ drug development programs with quality always the foundation of every study. Sponsors have many options when selecting a CRO, but time and again, choosing BioPharma has proven to be the optimal choice ”.
Review BioPharma’s Full Regulatory History Here.
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma Services has clinical research facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing. For more information about BioPharma Services, please contact Ms. Anna Taylor, Managing Director at email@example.com