FDA 483 - Arlington Scientific, Inc - February 13, 2019

Arlington Scientific, Inc., a medical device manufacturer in Springville, UT, received a Form FDA 483 citing significant deficiencies in its design control procedures. The inspection revealed that the firm failed to adequately establish procedures for design verification and design review, and did not properly maintain its design history file. These observations indicate a lack of documented adherence to critical quality system requirements for medical devices.