FDA 483 - Innova Medical Group, Inc. - April 09, 2021

An FDA inspection of INNOVA MEDICAL GROUP, INC. in Pasadena, CA, revealed extensive quality system deficiencies related to their SARS-CoV-2 Antigen Rapid Qualitative Test system. The firm lacked established procedures for critical operations including device control, acceptance activities, nonconforming product management, supplier evaluation, corrective and preventive actions, complaint handling, and Medical Device Reporting. These widespread issues indicate a severely underdeveloped quality system, posing a high risk to product quality and regulatory compliance.