FDA 483 - Baylab USA, LLC - May 20, 2025

Baylab USA, LLC, a manufacturer of Class II face masks in Dallas, TX, received a Form FDA 483 with six repeat observations. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established design controls, inadequate supplier management, and failure to conduct internal quality audits. Additionally, the firm lacked written medical device reporting procedures and failed to comply with Unique Device Identifier (UDI) labeling and GUDID submission requirements for its medical devices.