Regulatory Focus™ > News Articles > 2021 > 6 > Warning letter: FDA blasts Innova for falsifying data, GMP violations

Warning letter: FDA blasts Innova for falsifying data, GMP violations

Posted 11 June 2021 | By Joanne S. Eglovitch 

Warning letter: FDA blasts Innova for falsifying data, GMP violations

Editor's note: This article has been updated to include a statement from Innova.

The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.
 
The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.
 
FDA also issued a safety notice on 10 June warning consumers not to use the company’s Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use, citing “significant concerns” about the device’s performance.
 
The warning letter said tests have been distributed in the US “without marketing approval, clearance, or authorization from FDA” and calls for the firm to take “immediate action” to cease the sale and distribution of unapproved products. Innova initiated a voluntary recall for the tests during the inspection on 24 March 2021, which FDA has deemed a Class I recall, the most serious category.
 
Investigators found “false or misleading” labeling on two test kits, the 25T configuration and the 7T configuration. Specifically, the labeling on the 25T model claimed a relative sensitivity of 96%, a relative specificity of 100%, and accuracy of 98.98%, yet these claims were not supported by clinical data.
 
Further, the clinical study data submitted in the firm’s request for an Emergency Use Authorization (EUA) was “identical” to data previously provided by other manufacturers in their EUA requests.
 
The warning letter cites the firm for seven GMP violations. One deficiency was a failure to establish procedures for controlling and distributing finished devices. For example, while the devices were shipped to four states in during January and February 2021, there were no records documenting that they were even approved for release.
 
Another deficiency was the firm’s failure to inspect or test the kits after receiving them from a contract manufacturer in China yet shipped them anyway to end users.
 
The company also had inadequate procedures for segregating nonconforming products. Thirteen cartons of nonconforming test kits were in a storage room, yet not identified as such.
 
FDA said the firm should take “prompt” action to address these violations.
 
In a statement to Focus, an Innova spokesperson said, "the inspection, Innova has worked diligently and proactively to address the FDA findings. FDA’s June 10 letter acknowledged a number of corrective actions. Some of the corrective actions have been completed, while some are still underway. None of the inspectional observations concern the performance of the test."

Regarding the data appearing in an EUA request for the tests, the spokesperson said, "It’s not clear what FDA is referring to, but we know that our OEM manufacturer submitted data to FDA without pursuing EUA and Innova later submitted equivalent data for EUA for the same test under the Innova brand."
 
Warning Letter

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe