The US Food and Drug Administration (FDA) visited Celltrion’s biomanufacturing site in Incheon, South Korea in May and June this year and yesterday published the Form 483 giving details of 12 observations made by the inspectors.
This included an issue with vial stoppers which the FDA said has caused 140 complaints since the fourth quarter of 2015. Many details in the form (published below) have been redacted, but Celltrion is accused of failing to adequately implement corrective and preventive actions and to investigate foreign matter detected in drug product and substance in a timely manner.
Aseptic conditions at the facility were also subject of several observations, with the FDA finding fault in both equipment and operating procedures.
For example: “An operator was observed to perform an intervention during filling to remove a jammed stopper by reaching over the exposed stoppers in the stopper bowl with the Restrictive Access Barrier system (RABS),” the FDA wrote.
‘Common regulatory procedure’
Celltrion remained confident the observations are fixable and will not jeopardise production.
“The issuance of FDA form 483 is a common process of FDA routine GMP inspection,” spokesperson Gunn Lee told this publication.
“During the inspection, Celltrion provided responses and proposed corrective actions to the inspector for these 12 observations, and the official responses were submitted in written on 22nd of June, 2017 according to the FDA inspection procedure.”
The site, which boasts 140,000L of mammalian cell culture capacity, makes a number of marketed biosimilar products distributed through Celltrion Healthcare to partners, including Pfizer’s Inflectra (infliximab) which is available in both the EU and the US.
“Celltrion is confident that no drug product batches have been released to both the US and EU market that may have any potential quality issue listed in the form 483,” Lee said.
During a visit to the facility last year, VP of manufacturing Jeong Won Yun spoke to Biopharma-Reporter about the firm’s commitment to quality.
Workers receive training on standard operating procedures on a regular basis, he told us, and a number of signs posted around the site reiterated the importance of quality in both Korean and English.
“If you don’t feel that you could inject that into yourself or family then you don’t belong here,” he said.