美国FDA给予药企的警告信(含中文翻译).docVIP

WARNING LETTER CMS 535005 December 19, 2017 VIA UPS NEXT DAY AIR Paul F. Devine, CEO/PresidentC.O. Truxton, Inc.136 Harding AvenueBellmawr, NJ 08031 Dear Mr. Devine: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, C.O. Truxton, Inc. (揟ruxton?, at 136 Harding Avenue, Bellmawr, New Jersey (FEI 2220338), from April 17 to June 1, 2017. This warning letter summarizes significant violations of current good manufacturing practices (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because 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 (FDC Act), 21 U.S.C. 351(a)(2)(B). In addition, your firm mislabeled drug products, causing them to be misbranded under section 502(b)(2) and 502 (e)(1)(A)(ii) of the FDC Act, 21 U.S.C. 352(b)(2) and 21 U.S.C. 352(e)(1)(A)(ii). By introducing adulterated and misbranded drugs into interstate commerce you are in violation of section 301(a) of the FDC Act, 21 U.S.C. 331(a). We reviewed your June 14, 2017, response in detail. During our inspection, our investigator observed specific violations including, but not limited to, the following. CGMP Violations 1.牋?Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Your firm failed to establish a quality control unit for your drug repackaging operation and you lacked written procedures for production or quality unit responsibilities. You did not address this observation in your response. You stated that 搒ome items were not addressed, as they should not have been done and will not be done by C.O. Truxton Inc., in the future.?We are unclear as to w