# FDA 483 - Dimension Inx Corp. - February 27, 2025

Source: https://www.keypedia.com/records/483/dimension-inx-corp/cb4cdb99-405c-4b68-abd1-1803f0001717

> FDA 483 for Dimension Inx Corp. on February 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dimension Inx Corp.
- Inspection Date: 2025-02-27
- Product Type: device
- Office Name: Chicago District Office
- Summary: Dimension Inx Corp., a medical device manufacturer in Chicago, was cited for two observations during an FDA inspection from February 25-27, 2025. The firm failed to adequately validate the sterilization process for its CMFlex medical device, specifically lacking a completed performance qualification. Additionally, the company has not established adequate procedures for sampling methods, including a statistical rationale for its manufacturing performance qualification study.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/dimension-inx-corp/824a1f13-169a-4443-85b0-4f88b67e42c7

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669