# FDA 483 - DSM Biomedical, Inc. - February 12, 2026

Source: https://www.globalkeysolutions.net/records/483/dsm-biomedical-inc/d8755ce2-7ada-4b45-9fba-60afd2b125c9

> FDA 483 for DSM Biomedical, Inc. on February 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSM Biomedical, Inc.
- Inspection Date: 2026-02-12
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of DSM Biomedical in Exton, PA, a medical device manufacturer, identified two observations concerning the manufacturing and distribution of Augment Injectable Bone Graft Matrix. The firm was cited for issues related to the validation of a design change and equipment modification, as well as the lack of stability data to support established expiration dates for raw materials.

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/dsm-biomedical-inc/7a6db46d-6f3e-4e92-8fde-1d4f124bdc5e

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7