FDA releases Form 483 addressing inspections of the Celltrion Incheon

Sep 6, 2017

FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.

Print Page Mail Article