Food and Drug Administration Establishment Inspection Report – Celltrion Inc

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Inspection Summary
A post-approval and GMP inspection of this foreign drug substance and drug product manufacturer was conducted per FY17 work plans. The firm manufactures one product for the US market, Inflectra (infliximab-dyyb) under BLA 125544. Coverage was given to compliance program 7346.843, Post-Approval Inspections, compliance program 7356.002A, Sterile Drug Process Inspections, and
compliance program 7356.002M, Inspections of Licensed Biological Therapeutic Drug Products. The Quality, Facilities & Equipment, Production, and Laboratory systems received coverage.

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