![]() These violations are described in more detail below. Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. Your products “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” are also misbranded drugs in violation of section 502(f)(1) of the FD&C Act, 21 U.S.C. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. Your firm manufactures “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg.” These products are unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. See 21 CFR, parts 210 and 211.īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your 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. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Torrent Pharma, Inc., FEI 3004536846, at 2091 Hartel Ave., Levittown, Pennsylvania, from March 11 to April 9, 2019. Issuing Office: Division of Pharmaceutical Quality Operations I
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