# FDA 483 - 3-D Matrix, Inc. - November 17, 2021

Source: https://www.keypedia.com/records/483/3-d-matrix-inc/043ac499-17be-4bb2-acbf-d1d283f327b8

> FDA 483 for 3-D Matrix, Inc. on November 17, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: 3-D Matrix, Inc.
- Inspection Date: 2021-11-17
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 3-D Matrix, Inc. in Newton, MA, a medical device manufacturer, was cited with six observations during an FDA inspection. Deficiencies included a lack of established acceptance criteria for validation activities, failure to report a device removal involving a potential risk to health, inadequate corrective and preventive action procedures, and insufficient control over non-conforming products. Additionally, the firm failed to maintain proper records of changes and lacked written Medical Device Reporting (MDR) procedures for adverse events.

## Related Documents

- [483 - 2023-10-18](https://www.keypedia.com/records/483/3-d-matrix-inc/7e01b524-ef73-4cc0-951a-0ba8d6284c8e)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/3-d-matrix-inc/3d73f038-090a-41a2-a6f4-ec67e4fc30f3

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94