Sartorius Korea Biotech Co., LLC. – FDA 483, May 20, 2022

Sartorius Korea Biotech Company Limited, a testing laboratory in Seongnam-Si, Gyeonggi-do, was cited for significant deficiencies in its quality system. Observations include inadequate deviation investigations, lack of detailed written procedures for laboratory operations and contamination control, deficient laboratory record-keeping, and insufficient equipment qualification and employee training. These issues indicate a lack of robust controls to assure product quality and purity.