483
Bionet Co., Ltd.Bionet Co., Ltd. – FDA 483, Feb 18, 2019
Record Details
During an inspection from February 18-21, 2019, Pionet Co. Ltd. was cited for inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the firm's CAPA procedure was not adequately implemented, as nonconformities were not consistently reviewed as inputs into the system. This indicates a significant lapse in a fundamental quality system process.
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ID · 84b143c8-851b-4883-a94a-8e2bf4ca60bb
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