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BioPharma Services Completes 3 FDA Inspections

No Form 483’s reported

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioPharma Services has completed 3 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 2 weeks, the back-to-back inspections focused on a total of 9 studies including 4 bioanalytical validations that were conducted in support of ANDA and NDA filings to the FDA. All 3 inspections concluded without a 483 Form being issued.

BioPharma’s U.S.-based clinical facility in Columbia, MO, underwent 2 sequential FDA inspections. Since its opening in 2014, the clinical site has completed a number of programs to support drug submissions to the FDA and is poised to undergo a clinical expansion to 120-beds this summer.

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