Celltrion Inc. received a form with 12 flaws in Remsima production from the US Food and Drug Administration (FDA) in June. Remsima, Inflectra in the US, is Celltrion's biosimilar referencing J&J's blockbuster autoimmune disease treatment Remicade.
According to the US Regulatory Affairs Professionals Society (RAPS) on September 7, the FDA visited Celltrion’s biomanufacturing site in Yeonsu-gu, Incheon, in May and June and published a Form 483 giving details of 12 observations made by the inspectors. This was because the South Korean company failed to meet the Good Manufacturing Practice (GMP) Regulations.
The form includes several repeat observations that Celltrion received in 2015. According to the form, FDA inspectors found that the source of particles detected in a visual inspection "has not been identified." One of the critical observations "refers to problems with the vial stopper and states FDA received 140 complaints from physicians in Europe about the stopper.
In addition, the FDA pointed out that some of sterilization process were not properly operated and found flaws in systems that monitor asepticism as well as some inappropriate designs in the manufacturing facilities.