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# Warning Letter Close Out for Innova Medical
- URL: https://www.fdaweb.com/warning-letter-close-out-for-innova-medical/
- Published: 2022-10-24T12:00:00.000Z
- Updated: 2026-09-14T18:04:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153035

FDA has closed out a Warning Letter issued to Innova Medical Group in 2021 that cited its SARS-CoV-2 Antigen Rapid Qualitative Test because it was being marketed without approval, clearance, or authorization from the agency. The letter was issued following two FDA inspections ([see earlier story](https://www.fdaweb.com/innova-medical-warning-on-covid-test/)), which also found that clinical data submitted in Innova’s emergency use authorization request for the Covid test were identical to data previously provided by other manufacturers in their separate EUA requests. “The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health,” the letter said.

Innova said that a recent FDA inspection led to the close-out letter. “The evidence presented to FDA during the inspection demonstrated that Innova had successfully addressed the Warning Letter,” it said. “The inspection was successfully completed with no observations and no Form 483.”