Daniel J. Elliot
Chief Executive Officer
Innova Medical Group, Inc.
800 E. Colorado Blvd., Suite 288
Pasadena , CA 91101
United States
Daniel.elliott@innovamedgroup.comFEI 3018074194Issued Jun 10, 2021Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018074194.
Violations8
Issue DateJun 10, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Innova Medical Group, Inc.
Location
Daniel J. Elliot
Chief Executive Officer
Innova Medical Group, Inc.
800 E. Colorado Blvd., Suite 288
Pasadena , CA 91101
United States
Daniel.elliott@innovamedgroup.com
FEI Number
3018074194
Country
United States
Issue Date
June 10, 2021
Issuing Office
Center for Devices and Radiological Health
Product Type
Drugs
Status
Open
Summary
Innova Medical Group manufactured and distributed SARS-CoV-2 antigen rapid test kits without FDA marketing approval, clearance, or authorization, making the products adulterated under federal law. FDA inspections of the company's facilities in Pasadena and Brea, California between March and April 2021 found that the INNOVA COVID-19 Self-Test Kit and related configurations were being sold commercially without required premarket approval (PMA) or investigational device exemption (IDE). The products were also misbranded because the company failed to notify FDA of its intent to introduce the devices into commercial distribution.
Innova Medical Group, Inc. FDA Warning Letter, June 10, 2021
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