# FDA 483 - SigmaGraft Inc - April 25, 2025

Source: https://www.globalkeysolutions.net/records/483/sigmagraft-inc/c828b71b-8e8b-458b-a466-a63b77e0f11c

> FDA 483 for SigmaGraft Inc on April 25, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SigmaGraft Inc
- Inspection Date: 2025-04-25
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: SigmaGraft Inc. in Fullerton, CA, an HCT/P establishment, was cited for a significant deficiency during an FDA inspection. The firm failed to establish and maintain procedures, including release criteria, for the distribution of human bone tissue products. This lapse resulted in the distribution of numerous units without a proper Standardized Operating Procedure.

## Related Officers

- [Melsomar R. Ramos](https://www.globalkeysolutions.net/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)

Company: https://www.globalkeysolutions.net/companies/sigmagraft-inc/e7ec398d-8c04-4805-b60f-f4dc51b35f5f

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