First FDA Inspection passed with ZERO Observations

BAAT Medical holds an Established FDA Registration & Multiple Device Listings at the FDA, his reflects our strong commitment to compliance and quality. In mid-August 2025, we successfully completed our first FDA inspection. The FDA inspector found zero observations during the review, which focused on Quality System Regulation (QSR) and Good Manufacturing Practice (GMP). This result shows the strength and reliability of our processes.

We designed our Quality Management System to be efficient and thorough. It avoids unnecessary complexity while covering all critical requirements. Moreover, our documentation framework ensures clarity, traceability, and consistency across development and manufacturing activities. These elements form the backbone of our operations and guarantee rigorous control in every project.