Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes. cepacia contamination in your pretreatment and downstream distribution system.
Subsequent sampling of your water system revealed an adverse pattern of B. An investigation identified your water system as the source of the contamination. Notably, your firm isolated Burkholderia cepacia from manufacturing equipment rinse samples. Among the sanitary design deficiencies in the water system were multiple dead legs and threaded pipe connections. Your (b)(4) water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met (b)(4) Water, (b)(4) specifications and appropriate microbial limits. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). We reviewed your April 30, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.ĭuring our inspection, our investigator observed specific violations including, but not limited to, the following.ġ. 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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