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

An FDA inspection of Digital Diagnostics Inc., a medical device manufacturer, was conducted from November 7-10, 2022. The inspection uncovered two primary quality system deficiencies related to the company's IDX-DR Client and Analysis System, a software medical device. The first observation indicated that procedures for corrective and preventive actions (CAPA) were not adequately established. Specifically, company protocols did not require analyzing customer complaints to identify the root causes of non-conforming products or quality issues. Two complaints, concerning software bugs that affected image processing and analysis system performance for multiple customers, were resolved via software updates without a formal root cause investigation or CAPA initiation.

The second observation revealed that Digital Diagnostics Inc. failed to maintain records of non-reportable device correction or removal actions, directly contravening its own established procedures. The same two software-related complaints, which were considered non-reportable corrections, were not documented in the required log. The regulatory framework for these observations stems from the Federal Food, Drug, and Cosmetic Act concerning medical device quality system requirements. Digital Diagnostics Inc. acknowledged both observations and committed to implementing the necessary corrective actions to address these findings.