FDA 483 - Yuhan Chemical Inc. - January 12, 2024

An FDA inspection of Yuhan Chemical, Inc., an API manufacturer in Hwaseong, Gyeonggi, Korea, identified deficiencies related to the assurance that water samples are representative of water used during production. The firm's procedures for water sampling, documentation of sampling times, and collection of worst-case samples were found to be inadequate. These issues raise concerns about the quality control of water used in the manufacturing of active pharmaceutical ingredients.