AMCO International Manufacturing & Design, Inc.

Selected passages from the FDA letter

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

Passage 1

FDA has determined that your firm has not submitted a PMA by the February 3, 2022, compliance date for these devices and that your firm has continued to manufacture and distribute these devices after the compliance date. Consequently, your devices are adulterated under section 501(f)(1)(A) of the Act, 21 U.S.C. § 351(f)(1)(A), because they have been required by an order issued under section 515(b) of the Act, 21 U.S.C. § 360e(b), to have an approval under such section of an application for premarket approval, are not exempt from section 515 under section 520(g) of the Act, 21 U.S.C. § 360j(g), and your firm has not filed an application for premarket approval by the compliance date cited above.