FDA 483 - HatchMed Corporation - May 23, 2025

HatchMed Corporation, a manufacturer in Kent, WA, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in their quality system, specifically concerning the establishment and maintenance of procedures for corrective and preventive actions, purchasing controls, and equipment calibration and maintenance. These issues indicate a lack of robust quality system implementation crucial for regulatory compliance.