An inspection of the site in Songdo, Incheon by the US Food and Drug Administration in May and June last year resulted in a Form 483 with 12 observations, which has led to a warning letter issued to the firm this week.
“The letter raises issues related to certain manufacturing process at the facility,” Celltrion said in a press release. “We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with highest priority.”
The site, which houses 140,000L of mammalian cell culture capacity, makes biosimilar products for a number of biopharma companies including Inflectra, Pfizer’s version of J&J’s Remicade (infliximab) launched in the US in 2016.
But despite the warning, Celltrion said it is confident supply will not be affected.
“The warning letter does not affect Celltrion’s ability to manufacture and supply the Inflectra (infliximab-dyyb) products from Incheon site, South Korea, and the Company does not currently anticipate any impact on the supply of Inflectra (infliximab-dyyb) based on this warning letter.”
Further details were not made available and Celltrion did not respond to questions from this publication at the time of going to press.
Details from the inspection can be found in the Form 483, released by the Agency though heavily redacted.
Among the 12 observations, the FDA accused Celltrion of failing to appropriately review unexplained discrepancies in a timely manner, including foreign matter detected in drug product and drug substance.
The Agency also found deficiencies in Celltrion’s aseptic procedures and problems with documentation, including incomplete batch production records.