# FDA 483 - CXMedUS, Inc. - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/cxmedus-inc/a953cf5d-e613-45b8-a3a8-aeb008b4d457

> FDA 483 for CXMedUS, Inc. on April 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CXMedUS, Inc.
- Inspection Date: 2023-04-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: CXMEDUS, Inc. in Grand Blanc, MI, a medical device establishment, was inspected by the FDA, resulting in five observations. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the lack of documented and implemented procedures for complaint handling, medical device reporting, corrective and preventive actions, supplier management, and incoming product acceptance. These issues indicate a fundamental breakdown in the firm's ability to ensure product quality and compliance with regulatory requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/cxmedus-inc/05f9fcf6-71ce-42ba-80bc-6fcab285bfad

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