Eosera, Inc.April 28, 2025

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

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Record Details

An FDA inspection of Eosera, Inc. in Fort Worth, TX, identified two significant issues related to quality control and equipment maintenance for their OTC drug manufacturing operations. The firm failed to adequately follow written procedures for change management, specifically regarding a facility move, and lacked established cleaning validation procedures for equipment used in compounding OTC ear care products.

Company: Eosera, Inc.
Inspection Date: April 28, 2025
Product Type: Drugs
Office: Dallas District Office
People: Kevin T. Nguyen (investigator)
Shelby N. Turner

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