Bicooya Cosmetics Limited, FEI 3010671652, which was issued a warning letter on August 11, 2017. (b)(4), FEI (b)(4), which was issued a warning letter on (b)(4), for, among other things, not testing raw materials prior to use in drug manufacturing and not testing finished drug products prior to distribution.Ģ. For example, our inspections revealed that beyond the facilities detailed above, your firm has used the following contract manufacturers and suppliers:ġ. We also note that Greenbrier has, at various points in time, used contract manufacturers and suppliers with histories of significant drug CGMP violations. Additionally, in your Februresponse you state, "If a drug product is placed on Import Alert 66-40 (appearing not to comply with drug manufacturing cGMPs), Greenbrier ceases importing drug products from that establishment." The import data detailed above demonstrate this is not always the case. We note that during the inspection of your corporate headquarters, you stated that if you were made aware that a warning letter was issued to one of your suppliers or contract manufacturers, you would not purchase over-the-counter (OTC) drug products from that contract manufacturer any longer. FDA copied your COO on the outgoing warning letter. was placed on Import Alert 66-40 on Septemand was issued a warning letter on November 27, 2018. As a result of this and other violations, Hangzhou Zhongbo lndustiial Company, Ltd. in April of 2018 revealed significant CGMP violations, including the failure to test each batch of drug for conformance with specifications prior to release (21 CFR 211.165(a)). An inspection of Hangzhou Zhongbo Industrial Company, Ltd.
lmport records reviewed indicated that your firm received various (b)(4) and (b)(4) drug products from Hangzhou Zhongbo Industrial Company, Ltd., FEI 3008229416, from October through December of 2018. FDA copied your Chief Operating Officer (COO) on the outgoing warning letter.Ģ. As a result of these and other violations, Shanghai Weierya Daily Chemicals was placed on lmport Alert 66-40 on Septemand issued a warning letter on February 7, 2018. An inspection of Shanghai Weierya Daily Chemicals in April of 2017 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)). Import records reviewed indicated that your firm received Acne Treatment Pads and (b)(4) from Shanghai Weierya Daily Chemicals Factory, FEl 3010166363, on Octoand November 3, 2017, respectively. Our inspection and review of import data revealed the following:ġ. Receipt of Adulterated Drugs from Contract Manufacturers and Suppliers We reviewed your Februresponse in detail and acknowledge receipt of subsequent correspondence. Your 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.
However, the CGMP violations identified at your 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). The inspection revealed that you had limited manufacturing operations at your corporate headquarters. and stores your finished drug products, which it then distributes to Dollar Tree and other retail stores. This facility operates under the name Dollar Tree Distribution. Chesapeake, Virginia, from January 14 to 17, 2019. Additionally, FDA inspected your distribution center warehouse located at 1330 Executive Boulevard (FEI 3004319430).
#DOLLAR LETTER CHAIN CODE#
Significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR Parts 210 and 211 ). The FDA inspections of these foreign facilities revealed
Firms inspected by FDA included contract manufacturers used to manufacture Dollar Tree's Assured Brand drugs. (Greenbrier) (FEl 3005269673) at 500 Volvo Parkway, Chesapeake, Virginia, from January 14 to 18, 2019 after FDA inspections revealed violative conditions at multiple foreign drug manufacturers that supplied drugs to your distribution network. Food and Drug Administration (FDA) inspected your corporate headquarters, Greenbrier International, Inc. Issuing Office: Center for Drug Evaluation and Research
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