483
Tsukioka Film Pharma Co., Ltd.Tsukioka Film Pharma Co., Ltd. – FDA 483, May 24, 2019
Record Details
An FDA inspection of Tsukioka Film Pharma Co., Ltd. in Kakamigahara, Gifu, Japan, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate out-of-specification (OOS) investigations, unvalidated test methods for impurities, and poorly maintained equipment. These issues indicate a failure to ensure the quality, purity, and safety of drug products distributed to the United States.
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ID · 3909cbdc-b3bc-4084-970f-c577238d4291
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