FDA 483 - Clean Cosmetics, LLC - August 19, 2022

Clean Cosmetics, LLC in Moorpark, CA, a drug manufacturer, was cited for severe deficiencies in its quality control unit and overall manufacturing processes during an FDA inspection. The firm lacked a functional quality control unit, written procedures for critical operations, and adequate record-keeping, leading to the release of hand sanitizer products containing methanol without proper testing or batch control. These systemic failures indicate a significant lack of adherence to good manufacturing practices, posing potential risks to public health.