# FDA 483 - Materialise USA LLC - October 06, 2021

Source: https://www.keypedia.com/records/483/materialise-usa-llc/f8697b3a-db6a-4c38-8a7f-1fa8a1413723

> FDA 483 for Materialise USA LLC on October 06, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Materialise USA LLC
- Inspection Date: 2021-10-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Materialise USA LLC, a medical device manufacturer in Plymouth, MI, was cited for significant deficiencies in its design control processes during an FDA inspection. The firm failed to adequately establish procedures for design input, design verification, and design plans. Additionally, the risk analysis for its Class III tracheal splints was found to be incomplete.

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.keypedia.com/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

Company: https://www.keypedia.com/companies/materialise-usa-llc/dfc6dc25-82f8-406c-8e8a-019acf7c33cd

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0