483
Cytovance Biologics Inc.Cytovance Biologics Inc. – FDA 483, Sep 19, 2018
Record Details
Cytovance Biologics Inc., an API manufacturer in Oklahoma City, received a Form 483 citing three observations. The firm failed to conduct adequate investigations into discrepancies, did not fully qualify equipment used in manufacturing, and production personnel were not practicing good sanitation and health habits. These issues indicate deficiencies in quality control and facility maintenance.
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- Dallas District Office
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ID · f6df097a-5a8e-45c3-9153-af6bc24280ac
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