FDA 483 - Halo Dream, Inc ( formerly Halo Innovations, Inc.) - December 06, 2024

An FDA inspection of Halo Dream, Inc. in New York, NY, a manufacturer of Class II hospital bassinets, revealed significant deficiencies in their quality system. The firm failed to adequately document design verification results for product durability, establish comprehensive design plans and procedures, and document corrective and preventive actions for product complaints. These issues indicate a lack of robust controls over product design and quality management.