# FDA 483 - Dorel Juvenile Group, Inc. - April 25, 2024

Source: https://www.keypedia.com/records/483/dorel-juvenile-group-inc/81f3b043-99d7-4cc5-b62e-c21f212dc35e

> FDA 483 for Dorel Juvenile Group, Inc. on April 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dorel Juvenile Group, Inc.
- Inspection Date: 2024-04-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.keypedia.com/companies/dorel-juvenile-group-inc/7acc0947-11b1-406a-bcdd-f718b890e80c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0