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Re: DJPele post# 100985

Monday, 06/21/2021 5:14:27 PM

Monday, June 21, 2021 5:14:27 PM

Post# of 104572
"Innova's main website (prior to it going down for maintenance)."

The website has been down for a week, probably not maintenance. More likely related to this from the FDA Warning Letter.

Note, there are two response time frames specified. You should take immediate action to address the violations relating to your firm’s sale or distribution of the SARS-CoV-2 Antigen Rapid Qualitative Test. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Act.

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