Samsung Biologics Co., Ltd. – FDA 483, Sep 1, 2023

This FDA Form 483 details significant deficiencies at a manufacturing facility, particularly concerning its Manufacturing Scientific Analytical Technology (MSAT) laboratory and general production controls.

**Facility and Operations:** The MSAT laboratory supports application submission data for (b)(4) and (b)(4) and currently approved drug products for (b)(4). The facility includes Plant (b)(4) RABS Fill Line (b)(4) and Building (b)(4) Drug Substance Fill (b)(4) Grade C space.

**Violations and Observations:** * **Data Integrity (MSAT Lab):** Inadequate controls since 2013, including shared administration passwords, lack of data backup, and insufficient audit trails (DEV-010168). Internal assessments were deemed insufficient, and no third-party assessment was performed. The impact on commercially marketed products was not assessed. Repeated findings from internal audits (2021, 2022) and client audits (July, September 2022) were not timely addressed. Client notifications regarding deficiencies were delayed (October 2022 - January 2023). * **Production and Process Control Procedures:** * Failure to follow SOP-MFP-00293 regarding transition of (b)(4) bagged sterilized items into Grade A RABS, with portions of bags entering Grade A space. * Media fill video