FDA 483 - Nusmile, Ltd. - April 16, 2018

Nusmile, Ltd., a medical device manufacturer in Houston, TX, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including process validation, nonconforming product control, acceptance activities, CAPA documentation, equipment maintenance, complaint handling, and process control procedures. These issues indicate a systemic lack of adherence to established quality requirements for their MTA Gel products.