North American Diagnostics, LLC

Warning LetterOpen

Elizabeth A. Lashinsky Owner North American Diagnostics, LLC 618 Ridgewood Ave., Suite 100 Holly Hill , FL 32117 United States ealash52@gmail.comIssued Dec 27, 2022Center for Devices and Radiological Health

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

Violations7

Issue DateDec 27, 2022

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: North American Diagnostics, LLC
Location: Elizabeth A. Lashinsky Owner North American Diagnostics, LLC 618 Ridgewood Ave., Suite 100 Holly Hill , FL 32117 United States ealash52@gmail.com
FEI Number: N/A
Country: United States
Issue Date: December 27, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

North American Diagnostics, LLC manufactured and distributed multiple brands of SARS-CoV-2 antigen rapid test kits without obtaining required FDA marketing approval, clearance, or authorization, making the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. During a June 2022 inspection, FDA investigators documented that the company had distributed the COVID-19 test kits into U.S. commerce without the required premarket approval (PMA) or investigational device exemption (IDE), violations the company acknowledged in its official response. The products were also found to be misbranded under section 502(o) of the Act and lacked proper regulatory authorization, representing a significant compliance failure for a medical device manufacturer.

North American Diagnostics, LLC FDA Warning Letter, December 27, 2022