# FDA 483 - X-Cel X-Ray Corp - September 18, 2019

Source: https://www.globalkeysolutions.net/records/483/x-cel-x-ray-corp/568029ce-a39d-4451-999f-2c8a37db3ea4

> FDA 483 for X-Cel X-Ray Corp on September 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: X-Cel X-Ray Corp
- Inspection Date: 2019-09-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of X-Cel X-Ray Corp, a medical x-ray manufacturer in Crystal Lake, IL, revealed significant deficiencies in their quality system. Observations included inadequate documentation of rework activities in device history records, poorly maintained device master records, and incomplete design history files. Additionally, the firm lacked adequate procedures for controlling non-conforming products and failed to properly maintain complaint files, including details for reportable events and investigations.

## Related Documents

- [483 - 2022-03-04](https://www.globalkeysolutions.net/records/483/x-cel-x-ray-corp/e022d338-01ac-4ef2-9f7d-4750c38dfb3a)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/x-cel-x-ray-corp/654df456-7a31-4b4b-b09d-1ed45d3f47db

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