FDA 483 - Xlear Inc. - March 18, 2022

Xlear Inc. in American Fork, UT, was inspected and cited for nine observations related to its manufacturing and quality control practices. The inspection revealed significant deficiencies across materials sampling, stability testing, laboratory controls, quality unit procedures, record keeping, production phase time limits, and labeling controls. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting drug product quality and purity.