FDA 483 - Intelligent Retinal Imaging Systems Inc. - December 06, 2018

Intelligent Retinal Imaging Systems Inc. in Pensacola, FL, a medical device manufacturer, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate software validation documentation, poorly established design validation procedures, incomplete risk analysis, and insufficient procedures for complaint handling and corrective and preventive actions. These issues indicate a systemic lack of robust quality management practices.