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# FDA Celltrion Yeonsu-go Inspection Report Out
- URL: https://www.fdaweb.com/fda-celltrion-yeonsu-go-inspection-report-out/
- Published: 2018-04-03T12:00:00.000Z
- Updated: 2026-09-14T23:57:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141138

FDA has released the establishment inspection [report](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM603271.pdf?ref=fdaweb.com) from its 5/22-6/2/17 inspection at the Celltrion Yeonsgu-go Plant 1, Inchon City, Korea. The report says the inspection found that the firm continues to manufacture a drug substance, Inflectra (infliximab-dyyb), for the U.S. market as well as a lyophilized injectable drug product.

At the conclusion of the inspection, a 12-item FDA-483 was issued.