Knowles Surgery Center, LLCSeptember 11, 2019

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Knowles Surgery Center, LLC

Record Details

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.

Company: Knowles Surgery Center, LLC
Inspection Date: September 11, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West V
Person: Charles D. Boison

Open in Dashboard

ID · cccdd8a2-b400-486a-b638-1960b1f820ec