正文
For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.
你们通过复制粘贴原始API生产商分析结果的方式制作了多个API的COA，用你们的信笺抬头替换掉了生产商的信息，然后将这些COA签发给你们的客户。你们没有写上关键信息，包括原始生产商的名称和地址、实施该检验的化验室的名称、地址和电话号码。
Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.
客户和法规人员依赖于COA来获取药品及其成分的质量和来源信息。在COA上不提供这些信息使得供应链可靠信和可追溯性受到损害，可能会将客户置于风险之下。
2. Failure to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity.
未能控制API重新包装、重新标签和存贮操作以避免混淆和API识别性缺失。
Our FDA investigator documented unlabeled material in your “released for shipping” area. You told the investigator that this material was not to be released to customers, but was in fact intended for destruction.
我们的FDA检查人员记录下了在你们“发货放行”区的无标签的物料。你们告诉检查人员说该物料并不是要放行给客户，而是要进行销毁的。
To avoid mix-ups between materials that can and cannot be released, or between different API, you must repackage, relabel, and hold API under appropriate CGMP controls.
为了避免混淆可以放行和不可以放行的物料，避免混淆不同API，你们必须在恰当的CGMP控制下重新包装、重新标签以及存贮API。
Misbranding Violations
冒牌行为
The gabapentin API labels bear the statement “Manufactured under cGMP conditions by: Lumis Global Pharmaceuticals Co., Ltd.” This statement is misleading because it indicates that the manufacturer of the API is Lumis Global Pharmaceuticals Co., Ltd. instead of (b)(4). Therefore, the gabapentin APIs is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that the API labeling is misleading.
加巴喷丁原料药标签带有这样的声明：“由简德明康药业(武汉)有限公司在CGMP条件下生产”。该声明是误导性的，因为它标示生产商是简德明康药业(武汉)有限公司而不是XX。 因此，该加巴喷丁原料药根据《联邦食品、药品和化妆品法案（FD&CA）》第502（a）章节规定，因其标签带有误导性，是冒牌的。
In addition, section 502(b)(1) of the FD&C Act requires a drug to contain the name and place of business of the manufacturer, packer, or distributor of the drug. The label of Lumis’ API product is misbranded under section 502(b)(1) because it misidentifies Lumis, which is a distributor or packer, as the manufacturer. As evidenced by the certificates of analysis, (b)(4) is the manufacturer of the gabapentin API, not Lumis Global Pharmaceuticals Co. Ltd.
另外， FD&CA第502（b）（1）章节要求药品包含有生产商、分包商和分销商的名字、地址。简德明康的原料药根据章节502（b）（1）是冒牌的，因为它把分销商或者分包商，简德明康，标成生产商。由检验报告书可以证明，XX才是加巴喷丁的生产商，而不是简德明康药业（武汉）有限公司。
Shipping drugs from a manufacturer on FDA Import Alert 66-66
销售被列入FDA进口警报66-66的生产商的药品
