FDA 483 - Custom Smiles Sleep Department - March 18, 2022

Custom Smiles Inc. in Kannapolis, NC, a contract manufacturer of medical devices, received a Form FDA 483 with 13 observations following an inspection from March 14-18, 2022. The inspection revealed significant deficiencies across its quality system, including a lack of documented process validation, inadequate complaint handling, issues with device history records and labeling, and a complete absence of quality audits, management reviews, and established quality policies. These findings indicate a severely underdeveloped and non-compliant quality management system.