# FDA 483 - Cton Laboratories - July 25, 2025

Source: https://www.keypedia.com/records/483/cton-laboratories/a65594f9-c765-4583-8fcb-92e865b012eb

> FDA 483 for Cton Laboratories on July 25, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cton Laboratories
- Inspection Date: 2025-07-25
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CTON Corporation, a testing laboratory in Torrance, CA, was cited for significant deficiencies during an FDA inspection. The firm failed to establish and maintain core Current Good Tissue Practice (CGTP) procedures for the manufacture and testing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), particularly concerning communicable disease prevention and contamination control. Additionally, the quality program was not adequately established or maintained, and records lacked necessary detail for traceability.

## Related Documents

- [483 - 2025-07-25](https://www.keypedia.com/records/483/cton-laboratories/e7d41862-fa3a-4dd4-837a-0c59b280826f)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [FDA_PERSONNEL](https://www.keypedia.com/people/maurine-fadlalla/519e6e71-a50a-43b5-b41a-2249ec9afdd5)

Company: https://www.keypedia.com/companies/cton-laboratories/e1602f48-f4a8-43e6-9bb2-9f9d6f1b6ab0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6