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Badrivishal Chemicals & Pharmaceuticals
ViaUPS Warning Letter 320-17-28 Return Receipt Requested March 2, 2017 Mr. Deepak Rawat Chief Executive Officer Badrivishal Chemicals & Pharmaceuticals Plot No. 13, Revenue Colony Talegaon – Chakan Road Talegaon Dabhade, Dist. Pune 410 507 Maharashtra India Dear Mr. Rawat:
The U.S. Food and Drug Administration (FDA)inspected your drug manufacturing facility, Badrivishal Chemicals &Pharmaceuticals at Gat No. 29, Village Jambwade (Induri), Post Sudumbre, TalukaMaval, Dist. Pune, Maharashtra, from August 16 to 19, 2016. 美国FDA于2016于8月16-19日检查了贵公司位于马哈拉施特拉的药品生产场所。
This warning letter summarizes significant deviationsfrom current good manufacturing practice (CGMP) for active pharmaceuticalingredients (API). 本警告信总结了不符合原料药（API）CGMP要求的严重违规情况。
Because your methods, facilities, or controls formanufacturing, processing, packing, or holding do not conform to CGMP, your APIare 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. 351(a)(2)(B). 由于你们生产、加工、包装和存贮药品的方法、设施和控制不符合CGMP，根据FDAC501(a)(2)(B)和21U.S.C. 351(a)(2)(B) ，你们的药品被认为是掺假药。
We reviewed your September 8, 2016, response indetail. 我们详细审核了你们于2016年9月8日所发的回复。
During our inspection, our investigators observedspecific deviations including, but not limited to, the following. 在我们检查期间，我们的调查人员发现具体违规情况包括但不仅限于以下：
1. Failure to validate and monitorthe water purification system to ensure that water is of appropriate qualityand suitable for its intended use. 未能验证和监测水纯化系统以确保水具有适当的质量并适合其既定用途。
During the inspection, our investigators found thatyour water purification system was not adequately monitored and controlled.Because you use water as a drug component and for cleaning your facility andequipment, these failures pose significant risk to the safety of your drugs. 在我们检查期间，我们的调查人员发现你们的水纯化系统并未进行充分监测和控制。由于你们使用了水作为药品组分，并用于场所和设备清洁，这些问题对你们药品的安全性具有重大风险。
Source water 源水
You failed to test the source water for your (b)(4)water system. The source water emanates from a nearby river and passes throughfarmland, where it is subject to agricultural runoff and animal waste, beforereaching your facility. Your firm stores the source water in an (b)(4)tank that has a large (b)(4)-facing hole that is open to theenvironment. Your storage method does not protect your water from dirt andother contaminants, or from the ingress and proliferation of pests andobjectionable organisms. 你们未检查你们XX水系统的源水。源水来自附近的一条河，该河流经农地，在到达你们工厂之前受到农产径流和动物废物的污染。你们公司将源水存贮于XX罐中，该罐有一个很大的XX洞，直接连通环境。你们的存贮方法无法保护你们的水不受到脏物和其它污染物的影响，无法保护其不受到虫害和有害生物的侵入和滋生。
Sanitization and validation 消毒和验证
You did not follow your own sanitization proceduresfor your (b)(4) water system. Your procedures specify (b)(4) ofsanitization at (b)(4), yet our investigators identified instances whereyou sanitized for as little as 10 minutes without justification. 你们的XX水系统没有遵守你们自己的消毒程序。你们的程序说XX应按YY周期进行消毒，但我们调查人员发现你们未经论证只消毒10分钟的情况。
During the inspection, you stated that in March 2016you initiated, but have not yet completed, a performance qualification of the (b)(4)water system. Your firm has used this unqualified system routinely since itsinstallation in 2014, despite having no scientific evidence that the system iscapable of producing water of adequate quality. 在检查期间，你们声称你们于2016年3月开始了XX水系统的性能确认，但尚未完成。你们公司自2014年安装后即开始常规使用此未经确认的系统，而不管其实你们并没有科学证据证明该系统具备产生足够质量水的能力。
Testing 检测
Our investigators found that you were aware that thetotal aerobic microbial counts (TAMC) for all in-process water samples (b)(4)had exceeded your limit of (b)(4) colony forming units (cfu)/mL formultiple months. You failed to investigate these deviations. 我们的调查人员发现你们知道所有中控水样XX已经持续多月超出你们的总有氧菌计数（TAMC）微生物限度XXCFU/ml，而你们并没有对这些偏差进行调查。
Furthermore, your firm did not demonstrate an adequateunderstanding of the process that your (b)(4) water system relies on tokill microorganisms. (b)(4) is typically (b)(4)sanitizationsteps. However, you only use (b)(4) to reduce TAMC to acceptable levelsin the (b)(4) water. This suggests that it is a critical step in yourprocess, but you did not consider operating parameters that affect performance,such as water flow rate, (b)(4), water (b)(4), and(b)(4)age. Additionally, your interpretation of your results is confounded bythe fact that your methods are not verified. 另外，你们公司并没有证据证明你们对XX水系统所依赖的微生物杀灭系统有足够的了解，证明其是常规的XX消毒步骤。你们仅仅使用了XX来降低XX水中TAMC至可接受水平。这表明其在你们水处理工艺中是一个关键的步骤，但你们未考虑其影响性能的操作参考，如水流速度、XX、水YY和ZZ使用时长。另外，你们对你们结果的解释受到你们的方法未经确认的事实的影响。
In your response, you committed to testing your sourcewater for microbiological contamination. You indicated that you setmicrobial limits of (b)(4) cfu/mL for the source water, and that youremoved the microbial limits for the in-process samples of your (b)(4)water system. 在你们的回复中，你们承诺将测试你们源水中微生物污染。你们说你们设定了源水微生物限度为XX CFU/ml，你们删除了你们XX水系统里中控样品的微生物限度。
Your response is inadequate. You failed to providesufficient detail about how you will remediate your (b)(4) water system.In response to this letter, provide: 你们的回复是不充分的。你们未能提供如何弥补你们的XX水系统的足够细节。在回复此函时，请提交：
a plan to address the open (b)(4) source-water storage tank 一份计划，解决开放式XX源水贮罐 a status update of the performance qualification that you initiated in March 2016 你们于2016年3月开始的性能确认状态更新 corrective and preventive actions if source water test results exceed the limits 如果源水检测结果超出限度的CAPA scientific rationale for setting microbial limits 设定微生物限度的科学合理性
Contaminated (b)(4) water has been the rootcause of multiple recalls by other drug manufacturers of non-sterile (b)(4)liquids, including instances of adulteration with Burkholderiacepacia,an opportunistic pathogen. Therefore, it is imperative that appropriate actionand alert limits be established based on validation data; these limits must below enough to signal significant changes from normal operating conditions. 在其它非无菌XX液体制剂生产商多起召回中，受到污染的XX水是根本原因，其中包括洋葱伯克霍尔德菌，一种机会性病原体。因此，根据验证数据建立适当的行动限和警戒限是一种经验方法，这些限度必须足够低以在正常操作条件下区别重大变化。
Lumis Global Pharmaceuticals Co. Ltd.
ViaUPS Warning Letter 320-17-27 Return Receipt Requested March 2, 2017 Ms. Jocelyn (Jun) Ning Owner Lumis Global Pharmaceuticals Co. Ltd. Unit 305 Huishang Mansion Building A 2 Wudayuan Road Donghu New Technology Development Zone Wuhan, Hubei, 430073 China Dear Ms. Ning:
The U.S. Food and Drug Administration (FDA)inspected your drug manufacturing facility, Lumis Global Pharmaceuticals Co.Ltd. at Unit 305 Huishang Mansion Building A, 2 Wudayuan Road Donghu NewTechnology Development Zone, Wuhan, from September 26 to 28, 2016. 美国FDA于2016于9月26-28日检查了贵公司位于武汉市东湖新技术开发区武大园路2号徽商大厦A-305的药品生产场所简德明康药业（武汉）有限公司。
This warning letter summarizes significant deviationsfrom current good manufacturing practice (CGMP) for active pharmaceuticalingredients (API). 本警告信总结了不符合原料药（API）CGMP要求的严重违规情况。
Because your methods, facilities, or controls formanufacturing, processing, packing, or holding do not conform to CGMP, your APIare 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. 351(a)(2)(B). 由于你们生产、加工、包装和存贮药品的方法、设施和控制不符合CGMP，根据FDAC501(a)(2)(B)和21U.S.C. 351(a)(2)(B) ，你们的药品被认为是掺假药。
In addition, your gabapentin API is misbranded undersections 502(a) and 502(b)(1) of the FD&C Act, 21 U.S.C. 352(a) and352(b)(1). 另外，你们的加巴喷丁原料药根据FDCA的502(a)和 502(b)(1) 部分和 21 U.S.C. 352(a)和352(b)(1)部分认定为冒牌药。
We reviewed your November 9, 2016, response in detail.We note your response addressed some FDA observations, but did not address theissues noted below. 我们详细审核了你们于2016年11月9日所发的回复。我们注意到你们回复中解决了一些FDA发现的缺陷，但并没有解决以下问题：
During our inspection, our investigator observedspecific deviations including, but not limited to, the following. 在我们检查期间，我们的调查人员发现具体违规情况包括但不仅限于以下：
CGMP Deviations CGMP问题
1. Failure totransfer all quality or regulatory information received from the APImanufacturer to your customers. 未能将所有从API生产商处收到的法规信息和质量信息转达给你们客户。
You omitted the name and address of the original APImanufacturers on the certificates of analysis (COA) you issued to yourcustomers, and did not include copies of the original batch certificate. 你们在你们签发给客户的COA上没有写上原始API生商的名称和地址，也没有附上原始的批分析报告副本。
For multiple API, you generated COA by copying andpasting analytical results from the original API manufacturers, replacing themanufacturers’ information with your letterhead, then issuing these COA to yourcustomers. You omitted critical information, including the originalmanufacturers’ names and addresses and the names, addresses, and telephonenumbers 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、实施检测的化验室的名称、地址和电话号码。
Customers and regulators rely on COA for information aboutthe quality and sourcing of drugs and their components. Omitting informationfrom COA compromises supply-chain accountability and traceability, and may putconsumers 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 controlthe API repackaging, relabeling, and holding operations in order to avoid mixups 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 inyour “released for shipping” area. You told the investigator that this materialwas 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 cannotbe released, or between different API, you must repackage, relabel, and holdAPI 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。
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发表于 2017-3-18 16:42:43
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