FDA 483 - Yuhan Chemical, Inc. - September 22, 2017

An FDA inspection of Yuhan Chemicals Inc., an API manufacturer in Ansan-si, Gyeonggi-do, South Korea, revealed critical deficiencies in quality control and production. These issues included a failure to adequately investigate a customer complaint involving blood-contaminated API, the use of out-of-trend intermediate materials without proper justification, and insufficient controls over computerized systems and equipment cleaning. The findings indicate a lack of robust quality management practices that could compromise the safety and quality of APIs destined for the U.S. market.