483
Church & Dwight Co., Inc.FDA 483 - Church & Dwight Co., Inc. - April 27, 2018
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Record Details
Church & Dwight Company Inc, an API manufacturer in Old Fort, OH, received two observations during an FDA inspection. The firm's Quality Control Unit failed to timely close Quality Investigation Reports and monitor their effectiveness. Additionally, the inspection revealed inadequate controls over computer systems, including issues with data integrity, audit trails, user access, and data backup procedures.
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ID · cb43739c-9add-49f0-91c8-689e41b10879