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.
The news immediately triggered fresh jitters for Teva, which expects Celltrion to manufacture its CGRP migraine drug. Teva, though, immediately put out a statement saying that they remain on track to launch later in the year.
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.”
First published here, with additional reporting by Endpoints News. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
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