483
Huangshi Hygienic Material Medicine Co., Ltd.Huangshi Hygienic Material Medicine Co., Ltd. – FDA 483, Aug 30, 2024
Record Details
Huangshi Hygienic Material Medicine Co., Ltd. in Huangshi, China, was inspected and cited for significant deficiencies across multiple areas of its drug manufacturing operations. Key issues include inadequate stability and microbial testing, poor equipment cleaning and maintenance, lack of data integrity review, and facility disrepair. These observations indicate a systemic failure to adhere to good manufacturing practices for drug products intended for the US market.
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ID · 04cda052-522d-47fb-94b6-d9c82e2c260d
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