DMM Vission, S.A. de C.V.

Selected passages from the FDA letter

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

Passage 1

FDA laboratory testing of batches of these drug products detained at the border demonstrate that these drug products, labeled or declared to be manufactured at your facility, are adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C.

Passage 2

your Cleaner BY CRYSTALWARE HAND SANITIZER alcohol gel and SYP HEALTH HAND SANITIZER ALCOHOL GEL drug products are unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C.

Passage 3

these methanol-containing drug products, Cleaner BY CRYSTALWARE HAND SANITIZER alcohol gel and SYP HEALTH HAND SANITIZER ALCOHOL GEL, are misbranded under sections 502(j), (a), (e), (f)(2), (x) and (ee) of the FD&C Act, 21

Passage 4

SYP HEALTH HAND SANITIZER ALCOHOL GEL is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C 352(i).