Pasadena-Based COVID-19 Test Maker Receives Warning Letter from FDA

The U.S. Food and Drug Administration sent a scathing warning letter last week to Pasadena-based Innova Medical Group, billed as the world’s largest manufacturer of rapid antigen tests, accusing the company of a series of problems, ranging from distributing tests in the U.S. without FDA approval to mislabeling or misbranding tests.

The letter, dated June 10, demanded Innova take “immediate action to address the violations relating to your firm’s sale or distribution of the SARS-CoV-2 Antigen Rapid Qualitative Test.” It resulted from an inspection of the company’s Pasadena office, as well as manufacturing facilities in Brea in March and April, according to the FDA.

Innova test kits are widely used in the U.K. but have not been approved by the FDA for marketing in the U.S.

“Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA,” the letter stated.

The tests were also labeled indicating they provided higher levels of accuracy than was proven in clinical trials, according to the FDA.

Separately, inspectors expressed concern that clinical data submitted for the product’s qualitative test appeared “ identical to data previously provided by other manufacturers in their separate EUA requests,” the letter said. “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 inspection also found that “the methods used in, or the facilities or controls used for manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements,” the letter continued.

Innova representatives told STAT News that the issues brought up by the FDA are being corrected.

“Innova has worked diligently and proactively to address the FDA findings,” the company told STAT. “Some of the corrective actions have been completed, while some are still underway. None of the inspectional observations concern the performance of the test.”

Products distributed within the U.S. “to our employees, clinical studies and some customers for evaluation purposes” had been “voluntarily recalled,” the company told the publication.

With respect to allegations of inaccurate data provided for Emergency Use Authorization, “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,” according to the statement reported by STAT.

Innova’s website was not operating on Tuesday.

The FDA letter can be viewed online at fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innova-medical-group-inc-614819-06102021.