# FDA 483 - Elite BioFusion LLC - September 29, 2023

Source: https://www.keypedia.com/records/483/elite-biofusion-llc/5aa46161-8627-452f-a1b6-8a52972d0b98

> FDA 483 for Elite BioFusion LLC on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elite BioFusion LLC
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Elite BioFusion LLC in Anaheim, CA, was cited with three observations during an FDA inspection of its HCT/P storage, labeling, and distribution facility. The firm failed to establish adequate procedures for HCT/P receipt, shipment, and distribution, and lacked a comprehensive quality program to address CGTP requirements and complaints, including preventing communicable disease spread. Additionally, the records management system was found to be deficient, with critical records not readily identifiable or retrievable.

## Related Officers

- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/elite-biofusion-llc/db5c08ad-3b1d-4aa9-b144-2a83c0e25fd5

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