The U.S. Food and Drug Administration (FDA) has issued an additional “Form 483” based on its eight observations of inadequacy after inspecting Celltrion’s troubled plant in Korea.
The FDA sends Form 483 to drugs, food, medical devices, cosmetics, manufacturing businesses that violate the rules of procedures and internal systems. Companies that receive the warning letter must respond within 15 business days.
The FDA’s report cited a lack of written procedures for production and process controls, a lack of employee training, routine checking of automatic equipment and incomplete QC equipment log sheets.
The letter is the outcome of a re-inspection of the company’s facility and follows a warning letter for the site in January. The company also received another Form 483 in September last year.
Celltrion played down the meaning of the U.S. agency’s complaints, however.
“The Form 483 does not have anything to do with the quality of our pharmaceuticals and will not affect the approval schedule for Herzuma and Truxima,” a company official said to Korea Biomedical Review over the phone. “The recent Form 483 includes minor problems that were found during the recent auditing process.”
The company said it has sent a report to the FDA after correcting the problems and expects to receive approval for the sites.
“We are also discussing the pre-approval inspection (PAI) schedule for Herzuma and Truxima in close consultation with the FDA,” he said. “The company is expecting U.S. approval for both products in the fourth quarter of this year.”