FDA 483 - Fukuzyu Pharmaceutical Co., Ltd. - January 19, 2024

Fukuzyu Pharmaceutical Co., Ltd. in Toyama, Japan, an API manufacturer, was cited for four significant observations during an FDA inspection. The firm failed to conduct thorough investigations for out-of-specification results and critical deviations, and exhibited inadequate cleaning and maintenance of shared production equipment. Additionally, the inspection revealed incomplete validation of analytical methods and insufficient control over computerized systems and electronic records in the QC laboratory, indicating serious deficiencies in quality control and data integrity.