FDA 483 - POLARISAR INC - February 14, 2025

An FDA inspection of POLARISAR INC in Miami, FL, revealed two significant observations. The firm failed to adequately document personnel training according to its own procedures and did not submit required medical device information to the Global Unique Device Identification Database (GUDID), nor was it listed in GUDID. These findings indicate critical deficiencies in quality system compliance and regulatory reporting.