Celltrion receives Form 483 for troubled Korean site
The 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.
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