FDA 483 - Homtex Inc - October 16, 2025

Homtex Inc, a manufacturer/spec dev in Cullman, AL, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in acceptance activities, including undocumented testing results, lack of quality review for DHRs, and release of out-of-specification products. Additionally, the firm failed to adequately establish training procedures, with untrained personnel performing quality checks and the Director of Product Management lacking training records.