FDA 483 - Happiest Baby, Inc - July 25, 2025

Happiest Baby, Inc., a manufacturer of infant sleep systems, was issued a Form FDA 483 with four observations following an inspection. The firm demonstrated inadequate procedures for complaint handling, including issues with grouped complaints and MDR reportability. Additionally, deficiencies were noted in design change and design validation processes, particularly concerning new product sizes and accessory validation, alongside a failure to adequately establish corrective and preventive actions for nonconforming refurbished units.