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

The FDA issued a warning letter to Happiest Baby, Inc. on June 15, 2026, following an inspection of its Los Angeles facility conducted from July 21 to July 25, 2025. The agency determined that the company’s SNOO Smart Sleeper and SNOO Hospital Bundle violated the Federal Food, Drug, and Cosmetic Act through unauthorized modifications and significant quality system failures. A primary issue involves the introduction of X-Small and X-Large Sleep Sacks and a dedicated Hospital Bundle without obtaining necessary FDA clearance. The FDA noted that these changes altered the devices" safety profiles—introducing risks like respiratory compromise or suffocation—and expanded their use into clinical settings not covered by the original authorization. Furthermore, the inspection identified several quality management violations. Happiest Baby failed to properly investigate individual customer complaints, often grouping multiple safety reports into single files. The company also lacked documentation for product testing, failed to validate design changes for accessories like "Leg Lifters," and did not report a mandatory "correction" when replacing unsanitary refurbished units that posed infection risks. To comply with the regulatory framework, the company must transition its corrective actions to meet the new Quality Management System Regulation (QMSR) standards. Happiest Baby is required to respond in writing within 15 business days, providing a detailed plan and timeline for addressing these violations. Failure to take prompt action may result in regulatory consequences, including product seizures, injunctions, or civil penalties.