FDA Cites Digital Heat for Failing to Establish Design Procedures, CAPA

An FDA inspection of Digital Heat’s Tempe, Arizona facility conducted in December 2017 resulted in a nine-item Form 483 for failing to establish design procedures for the firm’s heated eye pad.

The device manufacturer had not established procedures for design inputs, outputs, verification activities, validation activities, transfer or design changes for the heated eye pad that the firm began distributing in September 2013.

The FDA inspector said the firm failed to establish a design history file to demonstrate that the design was developed to comply with 21 CFR Part 820.