PYRLess Group, LLC dba Dr. Fitt

Warning LetterOpen

Christy McCord PYRLess Group, LLC dba Dr. Fitt 812 S Georgia St Amarillo , TX 79106 United States questions@drfitt.comIssued Jan 25, 2021Center for Food Safety and Applied Nutrition

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJan 25, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: PYRLess Group, LLC dba Dr. Fitt
Location: Christy McCord PYRLess Group, LLC dba Dr. Fitt 812 S Georgia St Amarillo , TX 79106 United States questions@drfitt.com
FEI Number: N/A
Country: United States
Issue Date: January 25, 2021
Issuing Office: Center for Food Safety and Applied Nutrition
Product Type: Drugs
Status: Open

Summary

PYRLess Group, LLC dba Dr. Fitt marketed five unapproved drug products (Buffered C Powder, Get Well 2 Day Vit A, Get Well 2 Day Vit D3, Robynzyme, and OMG Cell Protek) with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 through their websites and social media platforms. The products violated the Federal Food, Drug, and Cosmetic Act by being sold as unapproved new drugs under section 505(a) and misbranded drugs under section 502. The enforcement action was undertaken during the declared public health emergency and national emergency period in response to COVID-19, reflecting FDA's urgent efforts to protect consumers from unproven pandemic-related treatments.

PYRLess Group, LLC dba Dr. Fitt FDA Warning Letter, January 25, 2021