# X-Ray Systems, Inc. – FDA 483, Mar 4, 2022

Source: https://www.keypedia.com/records/483/x-ray-systems-inc/e022d338-01ac-4ef2-9f7d-4750c38dfb3a

> FDA 483 for X-Ray Systems, Inc. on March 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: X-Ray Systems, Inc.
- Inspection Date: 2022-03-04
- Product Type: device
- Office Name: Chicago District Office
- Summary: X-Cel X-Ray Corp in Crystal Lake, IL, received a Form FDA 483 with five observations during an inspection of their manufacturing facility for Class II medical devices. The observations highlight significant deficiencies in their quality system, including issues with device history records, process validation, design output documentation, design verification, and device master record maintenance. Several of these issues, particularly concerning the device master record and process validation, were noted as repeat observations from prior inspections.

## Related Documents

- [483 - 2019-09-18](https://www.keypedia.com/records/483/x-ray-systems-inc/568029ce-a39d-4451-999f-2c8a37db3ea4) — date: September 18, 2019

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/x-ray-systems-inc/654df456-7a31-4b4b-b09d-1ed45d3f47db

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