483
Dorel Juvenile Group, Inc.FDA 483 - Dorel Juvenile Group, Inc. - April 25, 2024
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Record Details
An FDA inspection of Dorel Juvenile Group, Inc. in Columbus, IN, a specification developer, revealed significant deficiencies in their quality system. Observations included inadequate maintenance of complaint files for Class II thermometers, a lack of regular management reviews of the quality system, and a failure to perform internal quality audits at defined intervals.
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ID · 81f3b043-99d7-4cc5-b62e-c21f212dc35e