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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.

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