FDA 483 - Digital Diagnostics Inc. - November 10, 2022

An FDA inspection of Digital Diagnostics Inc., a medical device manufacturer in Coralville, IA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the analysis of complaints for non-conforming products. Additionally, the company did not maintain proper records for non-reportable device corrections, indicating a lack of adherence to their own procedures and regulatory requirements.