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Posted On: 06/11/2021 11:34:03 AM
Post# of 22465
Innovas response
In a statement emailed to STAT on Friday morning, an Innova spokesperson wrote: “Innova has worked diligently and proactively to address the FDA findings,” since the agency’s inspection of the company’s Pasadena office in March and April. “Some of the corrective actions have been completed, while some are still underway. None of the inspectional observations concern the performance of the test.”
The company acknowledged it had distributed products in the U.S. “to our employees, clinical studies and some customers for evaluations purposes” and said those had been “voluntarily recalled.” In response to the FDA’s allegations about falsified data in its EUA application, the statement said: “It’s not clear what FDA is referring to, but we know that our … manufacturer submitted data to FDA without pursuing EUA and Innova later submitted equivalent data for EUA for the same test under the Innova brand.”
In a statement emailed to STAT on Friday morning, an Innova spokesperson wrote: “Innova has worked diligently and proactively to address the FDA findings,” since the agency’s inspection of the company’s Pasadena office in March and April. “Some of the corrective actions have been completed, while some are still underway. None of the inspectional observations concern the performance of the test.”
The company acknowledged it had distributed products in the U.S. “to our employees, clinical studies and some customers for evaluations purposes” and said those had been “voluntarily recalled.” In response to the FDA’s allegations about falsified data in its EUA application, the statement said: “It’s not clear what FDA is referring to, but we know that our … manufacturer submitted data to FDA without pursuing EUA and Innova later submitted equivalent data for EUA for the same test under the Innova brand.”
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