Celltrion Receives Form 483 for Troubled Korean Site

Regulatory NewsRegulatory News | 08 August 2018 |  By 

The US Food and Drug Administration (FDA) late Monday released a Form 483 with eight observations for Celltrion’s South Korean site.

The observations during the re-inspection deal with a lack of written procedures for production and process controls, a lack of employee training and routine checking of automatic equipment not being performed according to the procedures written by Celltrion.

“The review of the visual inspection qualification records revealed your firm does not have a procedure to address an employee who repeated [sic] failed to identify a specific defects [sic] during all [redacted] qualification runs,” the Form 483 says.

The Form 483 follows two complete response letters (CRLs) in April, which the company attributed to a warning letter for the site from January. Last September, the site also received another Form 483.

Other violations found in the most recent Form 483, following an inspection 9-17 July, include deficient procedures describing the calibration of instruments and others with sections that are heavily redacted.

Celltrion told Focus in a statement: "Celltrion is making progress addressing the concerns raised by the FDA in a form 483 and is committed to working with the agency to fully resolve all observations with the highest priority and urgency.

"Celltrion is closely communicating with the agency to resolve outstanding issues by the end of August based on the results of re-inspection, which the issues are recognized feasible to clear."

Form 483

Updated on 8/8/18 with comments from Celltrion.


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