FDA 483 - Samsung Biologics Co., Ltd. - July 25, 2017

This FDA Form 483 document details observations from an inspection of a pharmaceutical manufacturing facility. The inspection identified several deficiencies related to laboratory controls, deviation investigations, and raw material testing.

**Laboratory Controls:** * **Observation 1a:** The method for a specific assay is not adequately verified or validated. Between January 22, 2016, and December 19, 2016, 9 out of 20 assays (45%) were invalid due to failing system suitability criteria, with 7 failures attributed to unexpected spike peaks. The root cause for these recurring failures is unclear, raising concerns about the method's consistency. * **Observation 1b:** Another assay method is also not adequately verified or validated. From December 12, 2016, to December 26, 2016, 6 out of 15 competition assays (40%) consecutively failed system suitability due to high absorbance. The root cause for these failures is also unclear, questioning the method's reliability. * **Observation 1c:** SOP-QC-4020 v.6.0 for reading and reporting microbial results lacks adequate instructions for reporting confluent microbial growth (spreaders) in bioburden tests. The procedure reports confluent growth as CFU regardless of the area covered, and no assessment has been performed to evaluate the impact of extensive spreader growth on the recovery of other organisms.