483
Zhejiang Guobang Pharmaceutical Co., LtdZhejiang Guobang Pharmaceutical Co., Ltd – FDA 483, Mar 3, 2025
Record Details
An FDA inspection of Zhejiang Guobang Pharmaceutical Co., Ltd. revealed significant deficiencies in laboratory controls related to their water systems used in drug substance manufacturing. The firm lacked scientifically justified specifications and test procedures for (b)(4) water, failing to ensure its identity, quality, and purity. This included inadequate microbial monitoring, failure to detect potential biofilms, and insufficient speciation of microorganisms in their water system.
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ID · 940729c8-9f67-4a2b-b16b-31436888e32a
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