FDA 483 - Eosera, Inc. - April 28, 2025

Eosera, Inc., an OTC drug manufacturer in Fort Worth, TX, received a Form 483 with two observations during an FDA inspection. The firm was cited for failing to adequately follow quality control unit procedures regarding changes to operations and for not establishing written cleaning validation procedures for manufacturing equipment. These issues indicate deficiencies in the firm's quality system and equipment maintenance practices.