FDA 483 - SoftSmile, Inc. - February 08, 2024

SoftSmile, Inc., a specification developer in Long Island City, NY, was inspected by the FDA from February 6-8, 2024. The inspection revealed six significant quality system deficiencies, including failures in maintaining MDR procedures, UDI database submissions, management reviews, quality audits, device master records, and design change procedures. These observations indicate a broad lack of adherence to established quality system requirements for medical devices.