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FDA Warning Letter Explorer
Medical Devices · Mar 4, 2021

Shenzhen Sunell Technology Corporation

5 extracted findings

FDA source excerpt, selected passage

At the start-up of 2020, Covid-19 had been sweeping through the mainland of China, and now is getting threatening worldwide. From the occurrence of the epidemic to today, Sunell's ''panda camera'' -- Body Temperature Measurement System played an important role in the work of prevention and control of epidemic. It has become the guardians for thousands of prevention and control site and points worldwide.

FDA published a close-out letter on Jul 27, 2023. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
At the start-up of 2020, Covid-19 had been sweeping through the mainland of China, and now is getting threatening worldwide. From the occurrence of the epidemic to today, Sunell's ''panda camera'' -- Body Temperature Measurement System played an important role in the work of prevention and control of epidemic. It has become the guardians for thousands of prevention and control site and points worldwide.
02
FIGHTING CORONAVIRUS WE ARE AT THE FRONTIER!
03
The Screening Cameras are offered for sale in the United States without marketing approval, clearance, or authorization from FDA.
04
your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
05
Your products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these products into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

For background, see Premarket notification (510(k)). Explore Botable’s work in Medical devices.

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