483
Yuhan Chemical Inc.Yuhan Chemical Inc. – FDA 483, Jan 12, 2024
Record Details
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.
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ID · f9cec592-4f35-411e-a903-f0bc3a806e3b
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