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

Source: https://www.globalkeysolutions.net/records/483/knowles-surgery-center-llc/cccdd8a2-b400-486a-b638-1960b1f820ec

> FDA 483 for Knowles Surgery Center, LLC on September 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Knowles Surgery Center, LLC
- Inspection Date: 2019-09-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/knowles-surgery-center-llc/3e33c826-1d4a-4683-ad61-320f814d05d4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b