FDA 483 - Titan Kogyo, Ltd. - December 08, 2023

An FDA inspection of Titan Kogyo, Ltd., an API manufacturer in Ube, Yamaguchi, Japan, revealed significant deficiencies in quality control and manufacturing practices. Observations included the use of raw materials prior to complete testing and release, an inadequate stability program lacking stability-indicating methods, and insufficient verification of raw material supplier Certificates of Analysis. Additionally, equipment and utensils were not adequately cleaned or maintained, posing a risk of contamination to drug substances.