FDA 483 - The Pyure Company Inc - January 20, 2023

The FDA inspected The Pyure Company Inc in Boynton Beach, FL, a manufacturer of the MDU/Rx Air Purifier. The inspection revealed significant deficiencies in design control, including undocumented design input requirements and inadequate design transfer procedures. Additionally, the firm failed to properly evaluate and select critical component suppliers, indicating a moderate level of non-compliance with quality system regulations.