483
Fujian Kerui Pharmaceutical Co., Ltd.FDA 483 - Fujian Kerui Pharmaceutical Co., Ltd. - March 14, 2018
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Record Details
An FDA inspection of Fujian Kerui Pharmaceutical Co., Ltd. in Fuqing, China, revealed issues with laboratory controls. Specifically, the firm failed to adequately document stability monitoring for active pharmaceutical ingredients. This indicates a lack of proper record-keeping for critical quality control processes.
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