FDA 483 - International Medical Development, Inc. - July 19, 2018

International Medical Development, Inc. in Huntsville, UT, a Class II medical device manufacturer, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in design control, including inadequate validation of process changes and a lack of established procedures for design changes. Additionally, the firm failed to adequately control non-conforming products and maintain proper documentation for acceptance activities within device history records.