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FDA Warning Letter Explorer
Medical Devices · Dec 4, 2023

Ostar Beauty Sci-Tech Co Ltd.

3 extracted findings

FDA source excerpt, selected passage

The FDA has reviewed your firm's website and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because for each of the above listed devices your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. §

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
The FDA has reviewed your firm's website and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because for each of the above listed devices your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. §
02
The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because for each of the above listed devices your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
03
As of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2023. Therefore, the listed devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360), and the devices were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 807.81(b)21 CFR 807.20(a)

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

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