RoyalVibe Health Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The FDA has reviewed your firm’s websites and attempted an inspection 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 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. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

The devices 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 the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2022. Therefore, all of your firm’s 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 were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).

Passage 4

You indicated that your firm uses this establishment as an address for customers in the United States to return their products for repair or replacement. Thus, you denied and/or limited an inspection of your establishment where your firm’s devices are processed, packed, and/or held (see Act § 501(j), 21 U.S.C. § 351(j)).