FDA EIR - Samsung Biologics Co., Ltd. - May 11, 2018

The U.S. Food and Drug Administration (FDA) conducted a pre-approval inspection of Samsung Biologics Corporation, Ltd.'s facility in Incheon, Korea, from May 07-11, 2018. This inspection was undertaken to assess the site's capability to manufacture a specific drug product, supporting an application to designate Samsung Biologics as an additional production location. The inspection adhered to regulatory guidelines including CP 7356.002M, CP 7346.832, and ICH Q7, focusing on the facility's Quality, Facilities and Equipment, Production, Materials, and Laboratory systems. During the inspection, five significant issues were identified and documented on an FDA Form 483. These primary observations included a failure to consistently follow procedures aimed at preventing microbial contamination in sterile drug products. Furthermore, the Quality Control Unit was found to lack adequate authority to review production records to ensure accuracy and prevent errors. Inspectors also noted instances where deviations from written Good Manufacturing Practice (GMP) procedures were not formally recorded. Other issues encompassed insufficient maintenance of equipment used in production and deficiencies in the environmental monitoring processes within aseptic processing areas. These observations necessitate that the company develop and implement comprehensive corrective actions to ensure full compliance with regulatory requirements for drug manufacturing.