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

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.