EnMed MicroAnalytics, Inc.

Warning LetterOpen

Edwin Naylor EnMed MicroAnalytics, Inc. 645 Meeting St, Suite 2 Charleston , SC 29403-4279 United States info@enmedmicroanalytics.comIssued Jan 25, 2021Center for Devices and Radiological Health

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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: EnMed MicroAnalytics, Inc.
Location: Edwin Naylor EnMed MicroAnalytics, Inc. 645 Meeting St, Suite 2 Charleston , SC 29403-4279 United States info@enmedmicroanalytics.com
FEI Number: N/A
Country: United States
Issue Date: January 25, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

EnMed MicroAnalytics, Inc. was selling COVID-19 sample collection kits (blood spot and saliva testing packets) through their website without FDA approval, clearance, or authorization, making the products adulterated under the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA) or investigational device exemption (IDE), and did not submit a 510(k) notification to FDA before distributing the devices, resulting in misbranding violations. These unauthorized COVID-19 diagnostic devices were being offered for sale and distributed in interstate commerce in violation of federal law.

EnMed MicroAnalytics, Inc. FDA Warning Letter, January 25, 2021