FDA 483 - Liposales LLC - August 05, 2021

An FDA inspection of Lipozales LLC in Houston, TX, a relabeler/repackager, identified five significant observations related to a lack of established written procedures. The firm failed to implement procedures for critical quality system elements including labeling control, product handling, complaint management, design output documentation, and acceptance activities. These deficiencies indicate a systemic failure to ensure product quality and compliance with regulatory requirements.