FDA 483 - Nexera Medical, Inc. - August 23, 2022

Nexera Medical, Inc. in Fort Lauderdale, FL, a specification developer, received a Form FDA 483 with one repeat observation. The firm failed to adequately establish and follow procedures for quality audits, specifically not performing internal audits since 2019 despite distributing SpectraShield Antimicrobial Respirator Masks. This observation was also cited in a previous 2012 FDA inspection.