In the letter, FDA said CGMP violations identified at the company’s suppliers caused drug products manufactured by these firms to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). And the firm’s receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301 (c) of the FD&C Act, 21 U.S.C. 331 (c).
Among the issues, FDA said the inspection and review of import data revealed that the company received Acne Treatment Pads from Shanghai Weierya Daily Chemicals Factory, which was placed on lmport Alert 66-40 on September 14, 2017 and issued a warning letter on February 7, 2018 after an April 2017 inspection revealed significant CGMP violations, including the failure to conduct component identity testing (21 CFR 211.84(d)(1)) and the failure to test each batch of drug for objectionable microorganisms prior to distribution (21 CFR 211.165(b)).
According to FDA, the agency also noted that Greenbrier has, at various points in time, used contract manufacturers and suppliers with histories of significant drug CGMP violations. As an example, FDA stated that inspections revealed that firm has used the following contract manufacturers and suppliers that include Bicooya Cosmetics Limited, which was issued a warning letter on August 11, 2017 (the firm was also placed on Import Alert 66-40 on June 29, 2017, for, among other things, not testing finished drug products prior to distribution and for rodent feces found throughout the manufacturing facility) and Ningbo Pulisi Daily Chemical Products Company, which was issued a warning letter on August 13, 2019. FDA said Ningbo Pulisi Daily Chemical Products was also placed on Import Alert 66-40 on June 10, 2019, for, among other things, not testing raw materials for identity prior to use in drug manufacturing, and not testing finished drug products prior to release.
FDA has asked Greenbrier to provide a detailed plan to ensure that it does not receive or deliver adulterated drugs in interstate commerce, in violation of section 301 (c) of the FD&C Act, 21 U.S.C. 331(c).