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

During an inspection conducted from July 21-25, 2025, the FDA identified significant deficiencies in Happiest Baby, Inc.'s quality management system for its Class II SNOO Smart Sleeper, an infant supine sleep system. The Form FDA-483 outlined four primary observations indicating non-compliance with regulatory frameworks for medical device manufacturing.

The first observation cited inadequate procedures for receiving, reviewing, and evaluating customer complaints. Happiest Baby, Inc. improperly grouped multiple complaints, failed to adequately assess medical device reportability for all reported issues, and lacked documented evidence for complaint investigations, such as measuring returned SNOO Sacks against specifications.

Secondly, the firm's design change procedures were found to be insufficient. New XS and XL sizes of the SNOO Sack accessory were introduced without conducting required testing or revisiting critical design control phases, including design validation, as mandated by the firm's own established procedures.

Thirdly, design validation procedures were deemed inadequate. The company did not sufficiently validate a critical user need related to preventing infant head entrapment. Documentation for design verification was non-compliant, and the firm used an unrepresentative baby model for validation without proper justification. Additionally, the SNOO Leg Lifters accessory lacked validation with the current SNOO Smart Sleeper device.

Finally, the firm's corrective and preventive action (CAPA) procedures were insufficient. Happiest Baby, Inc. failed to initiate formal CAPA reports for significant issues, such as widespread quality failures from a refurbisher, instead performing undocumented corrective actions.

These observations indicate a need for Happiest Baby, Inc. to revise its quality system to ensure compliance with medical device regulations. The firm has acknowledged these findings and promised to implement corrective actions for each observation.