Innova Medical Group, Inc. ("Innova"), a global leader in antigen testing, announced that it has received from the United States Food and Drug Administration ("FDA") a letter formally closing out the Warning Letter originally sent to the company on June 10, 2021.
This close-out letter was received following an on-site FDA field inspection where FDA reviewed, among other things, Innova's remediation of the concerns raised in the Warning Letter. The evidence presented to FDA during the inspection demonstrated that Innova had successfully addressed the Warning Letter. The inspection was successfully completed with no observations and no Form 483.
Dr. Charles Huang, Founder and CEO of Innova Medical Group Inc, said: "Innova Medical Group is committed to complying with all legal and regulatory requirements anywhere it operates or conducts business. Now, with FDA's Warning Letter behind us, Innova will focus its efforts in executing its mission of bringing innovative medical products to as many people as possible in the most efficient and effective manner."
About Innova Medical Group Inc.
Innova Medical Group is a global health screening and diagnostic innovator driven to dramatically improve health outcomes worldwide with equitable, high-value testing solutions. Its strategic and iterative approach is to create, build, deploy and distribute a wide array of innovative, accessible tests customized to meet and empower the user at their respective point of need. www.innovamedgroup.com
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Original Source: Innova Medical Group Announces Successful FDA Field Inspection Results and Formal Warning Letter Close-Out