483
Wuhan Hongren Biopharmaceutical Inc.Wuhan Hongren Biopharmaceutical Inc. – FDA 483, Sep 4, 2024
Record Details
An FDA inspection of Wuhan Hongren Biopharmaceutical Inc., a contract testing laboratory in Wuhan, China, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly investigate discrepancies, did not fully follow quality control unit procedures, and lacked appropriate controls over computer systems. Additionally, laboratory records were found to be deficient regarding test result comparisons to specifications.
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ID · 88832f27-179c-4d48-a03a-9d488c410758
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