Paragon 28, Inc. – FDA 483, Apr 24, 2025

An FDA inspection of Paragon 28, Inc. in Englewood, CO, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish process control procedures, leading to the production and release of non-compliant Patient Specific Talus Spacers and issues with product labeling expiration dates. Additionally, acceptance procedures were not properly established, resulting in the release of implants and instrument trials without sufficient documentation of conformance to design specifications.