FDA 483 - Footprint Medical, Inc. - September 21, 2018

Footprint Medical, Inc. in San Antonio, TX, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed inadequate process validation for its PIIC catheters, insufficient risk analysis, and a lack of a standardized review process for Medical Device Reporting. Additionally, production processes were not adequately developed to ensure device conformity to specifications.