FDA Warns Celltrion Over GMP Issues

Regulatory NewsRegulatory News
| 06 February 2018 | By Michael Mezher 

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Celltrion for good manufacturing practice (GMP) issues at the site where it produces its Remicade biosimilar, Inflectra (infliximab-dyyb).

The warning letter comes after an inspection of Celltrion's Incheon, South Korea manufacturing site in May and June 2017 that resulted in a Form 483 being issued to the company.

According to the warning letter, FDA observed "multiple poor aseptic practices" during the setup and filling of a batch of sterile drug product.

For instance, FDA said that to fix a jammed stopper during filing, a Celltrion employee reached over exposed sterile stoppers. "The [restricted access barrier system] RABS disrupted the unidirectional airflow over the stopper bowl, creating a risk for microbial contamination," FDA writes.

While FDA said that Celltrion submitted revised aseptic techniques in its Form 483 response, the agency says the revised procedure "permits contamination of product-contact surfaces during set-up" and requests that the company conduct a risk assessment to determine how past poor aseptic techniques may have impacted the quality and sterility of the company's products.

In addition, FDA said it observed deficiencies in the smoke studies Celltrion conducted and that the company had inadequate training and procedures for its personnel to examine media-filled units of product after incubation.

FDA also said that Celltrion failed to thoroughly investigate discrepancies in its products after receiving 140 complaints about the vial stoppers for one of its products. While FDA does not specify the exact issue with the stoppers, the warning letter notes that the defect could "significantly affect multiple quality attributes of [the] product over its shelf life."

And, FDA said, Celltrion did not implement a "timely and effective" corrective and preventative action (CAPA) or submit a biological product deviation report to the agency.

In a statement last week, Celltrion said it is making progress on the concerns cited in the warning letter and that the letter does not impact its ability to manufacture or distribute Inflectra (infliximab-dyyb) from the Incheon site.

Warning Letter


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