FDA 483 - Knowles Surgery Center, LLC - September 11, 2019

An FDA inspection of Knowles Surgery Center, LLC in Los Gatos, CA, revealed a significant deficiency in their quality program for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to document, implement, follow, and review an appropriate quality program, specifically evidenced by unreviewed freezer temperature logs over a 20-month period. This indicates a lack of adherence to Current Good Tissue Practices (CGTPs) requirements.