FDA Issues Warning Letter to Maker of Carpe AP

Cosco international Inc, maker of Carpe antiperspirant, received a Warning Letter from the US Food and Drug Administration (FDA). The Agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because Cosco’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, FDA deemed its drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Furthermore, the drug products “(b)(4),” “Carpe ANTIPERSPIRANT FOOT LOTION,” and “Carpe ANTIPERSPIRANT HAND LOTION” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the Federal Food, Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Additionally, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a), according to FDA.