# FDA 483 - MAST Biosurgery USA Inc - November 19, 2021

Source: https://www.keypedia.com/records/483/mast-biosurgery-usa-inc/0f1bf393-2675-4f3b-a2ee-073b9be1887a

> FDA 483 for MAST Biosurgery USA Inc on November 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MAST Biosurgery USA Inc
- Inspection Date: 2021-11-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of MAST Biosurgery USA Inc. in San Diego, CA, identified two significant observations regarding their medical device manufacturing operations. The firm failed to adequately validate a package sealing process for its SurgiWrap device, with re-qualification incomplete and required tests omitted. Additionally, procedures for corrective and preventive actions were found to be inadequately established, specifically concerning the basis for assigning risk scores to CAPAs.

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## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/mast-biosurgery-usa-inc/45a8cad6-1139-46ae-8b8e-ba716fe4e4b0

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