Wisconsin Devicemaker Nailed for Failure to Validate Device Change

May 14, 2019

A Pewaukee, Wisconsin device manufacturer was hit with a Form 483 after an inspection revealed the facility neglected to validate a device change for its mobile heart rhythm monitor.

During the FDA’s Feb. 6-8 inspection, the agency noted that Lohman Technologies did not properly validate changes it made to the operating software for its AfibAlert device in February 2016.

In addition, the firm did not properly maintain device master records for the heart rhythm monitor. Specifically, it lacked a device master record that included current labeling specifications recognizing the firm as the manufacturer and/or distributor.

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