FDA 483 - Liberty Mask LLC - December 15, 2023

Liberty Mask LLC, a manufacturer of KN95 Style Face Masks in Richardson, TX, was cited for numerous quality system deficiencies during an FDA inspection. The firm failed to establish adequate design controls, purchasing controls, acceptance activities, process validation, and internal quality audits. Additionally, the company did not properly control non-conforming products, maintain a device master record, or comply with Unique Device Identifier (UDI) labeling and database submission requirements for its medical devices.