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

On June 10, 2021, the FDA issued a Warning Letter to Innova Medical Group, Inc. following inspections from March 15 to April 9, 2021, at their Pasadena, CA, and Brea, CA facilities. The inspections revealed that Innova Medical Group, Inc. was manufacturing and distributing the SARS-CoV-2 Antigen Rapid Qualitative Test (also known as INNOVA COVID-19 Self-Test Kit) without FDA marketing approval, clearance, or authorization, rendering the device adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act.

The letter cited several Quality System regulation violations (21 CFR Part 820), including: - Failure to establish procedures for control and distribution of finished devices (21 CFR § 820.160(a)). - Failure to establish procedures for acceptance activities (21 CFR § 820.80(a)), leading to incorrect Instructions for Use (IFU) being shipped. - Failure to establish procedures to control nonconforming product (21 CFR § 820.90(a)). - Failure to establish procedures for corrective and preventative action (21 CFR § 820.100(a)). - Failure to establish procedures for receiving, reviewing, and evaluating complaints (21