# FDA 483 - Biomat USA, Inc - September 13, 2023

Source: https://www.keypedia.com/records/483/biomat-usa-inc/3456ad01-3754-4bc2-a3a0-4bf0da40a206

> FDA 483 for Biomat USA, Inc on September 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA, Inc
- Inspection Date: 2023-09-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Biomat USA, Inc, a Class II medical device manufacturer in City Of Industry, CA, was inspected by the FDA from September 11-13, 2023. The inspection identified a significant deficiency related to the firm's failure to develop written procedures for Medical Device Reporting (MDR). This indicates a critical gap in their quality system regarding the handling and reporting of adverse events.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/biomat-usa-inc/87c4c683-10f5-4773-a585-a44296a91b67

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