FDA警告信-香港北京制药厂再次被警告

巴西木

FDA警告信-香港北京制药厂再次被警告
香港北京制药厂2013年3月25日

卫生和人类服务部	公共卫生服务 食品和药物管理局
	马里兰州Silver Spring 20993

警告信

挂号信件                                                                        WL：320-13-12
回执所需

2013年3月25日


周Martin
香港北京制药厂
单位B，7 / F，第1期，利达工业中心
188-202号德士古道
荃湾，新界，香港
FEI：3004186759





尊敬的周先生：

我们在4月30日至2012年5月4日检查您的药品生产设施，北京制药厂，位于单位B.7 / F，新界，荃湾德士古道188-202号利达工业中心1期，香港，研究者从美国食品和药物管理局（FDA）身分ED显著违反现行良好生产规范（CGMP）规定的成品药，标题21，联邦法规法典，配件210和211。这些违规行为导致的药物产品（第）在第501（A）（2）的意思是掺假（B）联邦食品，药品和化妆品法案“（该法案），21 USC 351（A）（2 ）（B），所采用的方法，或用于设施或控制，他们的生产，加工，包装，或控股不符合，或者不按照经营或管理，CGMP。

我们的调查人员在检查过程中观察到具体的侵权行为，包括但不限于以下：

CGMP侵犯

1，    你的质量控制设备失灵影响的身份，实力，质量和纯度的药物产品的批准程序和规范。其次，你的质量控制设备失灵行使其权力批准或拒绝药物产品组件，容器，瓶盖，加工材料，包装材料，标签和成品。这种责任包括：审查生产记录，以确保没有错误发生，如果发生错误，他们已经得到了充分的调查，并批准或拒绝药品的生产，加工，包装或根据合同由另一家公司持有的要求。最后，有没有书面程序描述适用于质量部门的职责和程序。[21 CFR§211.22。

你的公司没有一个有效的质量控制单元（QCU）。违反的几个例子如下：

一）    你的质量单位没有批准的程序和规格影响成品药进口到美国市场的产品质量。

（一）    在检查中，我们的调查人员发现，你目前的程序还没有被审查和批准由QCU。这些未经批准的程序包括：完成产品发布，存储和分销（SOP-01-05）;成品稳定性试验（SMP-QC-016-00）;更改控制和验证（PS-10）;材料收据管理程序（RM-02）;产品召回管理（SMP-11-02）;及投诉和不良反应（SMP-12-01）。
（2）    此外，我们的调查人员还发现QCU未能建立和批准的标准操作程序（SOP）如下：清洁验证;成品释放和控制，变更控制，标签和包装业务;年度产品回顾及程序标准作业程序的编写，审查，批准。

二）    成品药产品已被释放您的仓库管理员，没有签署QCU。此外，未经批准的程序，SOP-01-05“成品放行，仓储和配送仓库解决如何释放材料，航运，而不是如何成品的检查，并批准您的QCU。  

三）    你的的QCU失败，建立标准作业程序，检查并确保传入的原材料，零部件，集装箱，倒闭，或标签的适用性。  
           

四）    你公司外判制造商强胡乐高外部人士，  你的企业是拥有这种药物产品，但没有充分评估是否合同生产组织（CMO），这是一个扩展您的操作，能始终如一地生产的产品适用于配电。例如，你的质量单位没有评估奇美，以便作出适当的处理决定（批准或拒绝）每批药品的质量。

E）   有没有书面程序或程序的解决产生任何贵公司生产的成品药产品的验证过程中使用的。  

F）   你的公司还没有建立QCU的具体职责描述的SOP。   

在这封信中，提供的书面及开发的程序适用于您的QCU，包括定义其角色和职责。当您准备的书面程序，请注意，一个CGMP标准的质量控制系统支持可持续发展的状态。这包括，但不仅限于，系统使用合适的原材料和零部件，可靠的制造工艺，严格的质量监控整个药品生产，和一个强大的纠正和预防措施程序。我们建议您寻求援助作出符合CGMP的要求，用于制造药物产品的改进，你将需要一个全面的评估，以确定一个第三方顾问的意见。

（2）    建立规格，标准，取样计划，测试程序，实验室控制机制，包括投票者，通过适当的组织单位起草，审查和批准的质量控制部门的任何变化。   你的公司已经建立了科学合理和适当的规格，标准，取样计划，旨 ​​在保证，成分，药品容器，瓶盖，加工材料，贴标，和药物产品的测试程序符合相应标准的身份，实力，质量和纯度。[21 CFR§211.160]

违反的三个例子，如下所示：

。    有没有规范，标准，取样计划，测试程序，和实验室控制机制QCU批准。  

（二）    你的企业还没有建立成品规格为强佑乐高。

（三）    你的公司缺乏校准实验室仪器或设备的书面程序。您在您的实验室的仪器或设备没有校准。   

在这封信中，提供药物的产品规格，以及抽样计划和所有的测试方法，包括身份和检测STRONG胡乐高的副本。提供书面计划如何将您的实验室仪器充分校准和适合其预期用途。

3，    测试和释放药物产品分布不具有令人满意的一致性包括适当的实验室测定之前最后规格与身份和强度的每种活性成分释放。[21 CFR§211.165（a）〕

。   你的成品，强胡乐高（很多II18A）没有测试是否符合标示量的活性成分。你的公司承包了强大的胡乐高的产品， 你的坚定接受和依赖分析证书（COA），合同制造商（CMO），并在农委会的测试结果的准确性和完整性验证失败。例如，强胡乐高包含6个活性成分。这个地段的COA表明，六两个活性成分进 ​​行唯一身份鉴定。没有进行化验测试。

在回应这封信，你应该根据适当的成品放行标准测试所有产品包括承诺。你的公司应该还包括一个计划，以解决很多已经在美国市场上的质量，   至少，你公司应及时提供测试结果保留所有药物产品批次样品的内到期，并分发到美国市场。

4，    你的公司没有足够的书面测试计划，目的是评估药物产品的稳定性的特点，以确定适当的储存条件和到期日。  [21 CFR§211.166（一）]

。   贵公司没有书面的测试程序，以评估药物的产品，雄厚的胡乐高稳定性的特点。此外，稳定程序（SMP-QC-01600），为新产品的设计仍然是一个草案，而不是审查和批准QCU。

二。你的公司并没有进行任何STRONG胡乐高稳定性研究。你的企业接受和依靠石膏制造商提供的失效日期。

（三）   你QCU没有充分确保该药物释放到市场上的产品，通过适当的稳定数据支持。

在这封信你的回应，提供的文件来支持当前的到期日期分配给你的药物产品，目前在美国的分销，以及一个承诺，以确保您的每一个药品的常规测试，根据已批准的程序，稳定QCU。

    收到书面程序缺乏足够的细节描 ​​述，识别，存储，处理，取样，测试，审批，元件，药品容器和密封件的拒绝。袋装或盒装的成分，药品容器和封不存储在地上，找不到适当的间隔，以允许清洗和检查。[21 CFR§211.80（a）和（c）条]

   您的书面程序。“材料收据管理办法”（文件编号RM-02）一直在为两（2）年草案和您的QCU从未批准。此外，这个过程只需要一个检验的正确性和验证的组件不被损坏的采购订单。

（二）   我们的调查发现，许多盒存储在仓库的地板上。你的仓库是不是能够提供足够的空间，以便清洗和检查。

在这封信中，提供了详细的收据，取样，测试和释放或抑制药物成分，容器和封纠正行动计划。

    你的公司已经至少进行过一次具体身份测试，并通过适当的验证供应商的测试结果的可靠性还没有建立对供应商的分析在适当的时间间隔[21 CFR§211.84（D）（1）]

。   我们的调查发现，贵公司没有来料进行身份鉴定，而只进行微生物检测。

在这封信中，提供了详细的纠正行动计划，以解决这方面的不足。

7，    你的公司没有确保员工接受培训的现行良好生产规范，以及分配给员工的特定操作[21 CFR§211.25（一）]。

一个   检查记录你的公司缺乏一个培训计划，并已收到你的员工，没有CGMP培训。

你的回应这封信，提供了一个发展计划，持续和稳健的CGMP为您的员工培训计划，包括解释你将如何评估培训效果。

未经批准，冒牌过的柜台交易（OTC）药物

除了CGMP违反，贵公司生产和/或分销STRONG胡乐高。基于此产品上的标记声明，强烈OO乐高是一种药物，所定义的第201条（g）项（1）“联邦食品，药品和化妆品法案”（该法案）[21 USC§321（克） （1）]，因为它的目的是用于预防，缓解，治疗或治愈的疾病，和/或意在影响身体的结构或功能。记录你的产品的预期用途的标签报表的例子包括，但不限于，下列：

• “（原文如此）对于暂时缓解痛，扭伤，受伤，肩膀和背部酸痛，腰痛和痛苦中强筋壮骨“
  

产品标签上宣称的成分：

• “活性成分：。。。精液罗汉果1.5％。。。精液蚕5％。。没药2％ 。。。乳香2％。。。薄荷脑5％。。。水杨酸甲酯1％“
  

强佑乐高是一个“新的药物，该法第201（P）”的定义[21 USC§321（P）]，因为这个产品是不是一般公认的安全和有效使用规定的条件下，建议，在其标签或建议。根据第301（d）和505的法案，可能不会被引入一种新的药物引入州际贸易或交付，除非它实际上是一个FDA批准的应用程序。分销上述产品未经批准的应用程序违反了该法的这些规定。

我们注意到，正在评估与疼痛有关的OTC适应症用于局部给药的药品，OTC药品审查下。最终暂定专着（TFM）1983年2月8日发行，非处方外用止痛剂（48 FR 5852）是本次评估的一部分。STRONG胡乐高根据本TFM不是盖的，因为它的配方包括活性成分“精液罗汉果”，“精液蚕”，“没药”，“乳香”和“薄荷脑”，其中没有包括在OTC药品审查任何迹象。此外，“骨”痛不包括在外部的镇痛TFM。因此，强胡乐高是不获列入OTC药品审查。

2012年4月5日发出一封警告信（300-12-007）没有进行登记，并列出规定21 CFR第207.40。请附上你的回应所采取的步骤，以符合这一要求。

这封信中提到的违规行为，不打算在您的工厂存在的侵犯是一个包容各方的列表。您是负责调查和裁定上述查明的侵犯的原因，并防止其复发和其他违规行为的发生。  

，直到所有的的的更正已经完成，并粮食与药物管理局已确认了了与违法行为和您的坚定的的与CGMP的的合规性的更正，粮食与药物管理局可能会代扣代缴的任何，新的的应用程序或营养补充剂列出您的的的作为一种药物产品制造商的坚定的的批准。此外，纠正这些侵犯你的失败，可能会导致的FDA拒绝录取，北京大学医学制造厂，单位B，7 / F，第1阶段，利达工业中心德士古道188-202号，荃湾，新界制品，到美国的香港特区，根据第801条（一）（3）款的规定，21 USC 381（A）（3）。文章须根据第801（A）（3）款的规定拒绝录取，21 USC 381（A）（3），在其生产中使​​用的方法和控制不符合CGMP内第501（A）（2）（B）该法的意义，21 USC 351（A）（2）（B）。

在15个工作日内收到这封信，请以书面形式通知本办事处的具体步骤，你已经采取了纠正和防止再次发生侵权行为，并提供支持文档的副本。如果你不能在15个工作日内完成纠正措施，国家延迟的原因和日期，你会已经完成了改正。此外，如果你不再生产或分发药物产品（第）发行，提供日期（s）和原因（S）你停止生产。请确定你的回应与FEI＃3004186759。

请您的回复发送到以下地址：

岩岩（珍妮）秦
高级政策顾问
美国食品和药物管理局
药品评价和研究中心
办公室生产和产品质量
国际药品质量部
白橡，51号楼，4235室
新罕布什尔州大道10903号
马里兰州Silver Spring 20993
电话：      （301）796-3207
传真：     （301）847-8741

                                                                       
真诚的，
/ S /
理查德·L·弗里德曼
署理署长
办公室生产和产品质量
合规办公室
药品评价和研究中心

Peking Medicine Manufactory 3/25/13

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Silver Spring, MD  20993

Warning Letter

CERTIFIED MAIL                                                                         WL: 320-13-12
RETURN RECEIPT REQUIRED

March 25, 2013

Mr. Martin Chow
Director
Peking Medicine Manufactory
Flat B. 7/F, Phase 1, Leader Industrial Centre
188-202 Texaco Road
Tsuen Wan, New Territories, Hong Kong, SAR


Dear Mr. Chow:

During our April 30 through May 4 2012inspection of your pharmaceutical manufacturing facility, Peking Medicine Manufactory, located at Unit B.7/F, Phase 1, Leader Industrial Centre, 188-202 Texaco Road, Tsuen Wan, New Territories, Hong Kong, an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

Our investigator observed specific violations during the inspection, including, but not limited to, the following:

CGMP VIOLATIONS

1.    Your quality control unit failed to approve procedures and specifications impacting the identity, strength, quality and purity of the drug product.  Secondly, your quality control unit failed to exercise its authority to approve or reject drug product components, containers, closures, in-process materials, packaging material, labeling and finished products.  This responsibility includes the requirement to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated, and approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. Finally, there are no written procedures describing the responsibilities and procedures applicable to the quality unit. [21 C.F.R. § 211.22].

Your firm failed to have a functioning quality control unit (QCU).  Several examples of the violation are as follows:

a)    Your quality unit has not approved procedures and specifications impacting the quality of finished drug products imported to the U.S. market.

(i)    During the inspection, our investigator found that your current procedures have not been reviewed and approved by the QCU.  Examples of these unapproved procedures include: Finished Product Release, Storage, and Distribution (SOP-01-05); Stability Testing of Finished Product (SMP-QC-016-00); Change Control and Validation (PS-10); Material Receipt Management Procedure (RM-02); Product Recall Management (SMP-11-02); and Complaint and Adverse reactions (SMP-12-01).
(ii)    Additionally, our investigator also found that your QCU failed to establish and approve standard operating procedures (SOPs) as follows: cleaning validation; finished product release and control; change control; labeling and packaging operations; annual product review; and procedure for writing, reviewing, and approving standard operating procedures.

b)    Your finished drug products have been released by your warehouse manager, not signed off by your QCU.  In addition, your unapproved procedure, SOP-01-05 “Finished Product Release, Storage and Distribution” addresses how your warehouse releases materials for shipping, not how your finished product is examined, and approved by your QCU.  

c)    Your QCU failed to establish SOPs to examine and ensure the suitability of incoming raw materials, components, container, closures, or labels.  
           

d)    Your firm contracted out the manufacturer of STRONG WOO LOK GAO to an external party. Your firm is the owner of this drug product, but did not adequately evaluate whether the CMO (contract manufacturing organization), which is an extension of your operations, can consistently produce product that is suitable for distribution. For example, your quality unit did not evaluate the quality of each batch of drug product produced by the CMO in order to make an appropriate disposition decision (approval or rejection).

e)    There is no written procedure or program to address the validation of processes used to produce any of the finished drug products manufactured by your firm.  

f)    Your firm has not established an SOP describing the specific responsibilities of the QCU.   

In response to this letter, provide the written procedures developed and applicable to your QCU, including defining its roles and responsibilities.  When preparing your written procedure, please note that a CGMP-compliant quality system supports a sustainable state of control. This includes, but is not limited to, systems to use suitable raw materials and components, reliable manufacturing processes, vigilant quality monitoring throughout drug manufacturing, and a robust program for corrective and preventive actions. We recommend that you seek the advice of a third-party consultant for assistance with a comprehensive evaluation to determine the improvements that you will need to make to meet CGMP requirements for the manufacture of drug products.

2.    The establishment of specifications, standards, sampling plans, test procedures, laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit, reviewed and approved by your quality control unit.  Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. [21 C.F.R. § 211.160]

Three examples of the violation are as follows:

a.    There are no specifications, standards, sampling plans, test procedures, and laboratory control mechanisms approved by your QCU.  

b.    Your firm has not established finished product specifications for STRONG WOO LOK GAO.

c.    Your firm lacks a written program for calibration of your laboratory instruments or equipment.  All of your instruments or equipment in your laboratory are not calibrated.   

In response to this letter, provide copies of your drug product specifications, as well as sampling plans and all test methods including the identity and assay for STRONG WOO LOK GAO. Provide a written plan how your laboratory instruments will be adequately calibrated and suitable for their intended use.

3.    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. [21 C.F.R. § 211.165(a)]

a.    Your finished product, STRONG WOO LOK GAO (lot#II18A) was not tested for conformance to the labeled amount of active ingredients.  Your firm contracted out the STRONG WOO LOK GAO product. Your firm accepted and relied on the Certificate of Analysis (COA) from your contract manufacturer (CMO) and failed to verify the accuracy and completeness of testing results in the COA.  For example, STRONG WOO LOK GAO contains six active ingredients. The COA for this lot showed that only identity testing for two of the six active ingredients was conducted. No assay testing was conducted.

In response to this letter, you should include a commitment to test all products according to appropriate finished product release specification.  Your firm should also include a plan to address the quality of the lots already on the U.S. market.  At minimum, your firm should promptly provide testing results for retain samples of all drug product lots within expiry and distributed to the U.S. market.

4.    Your firm does not have an adequate written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expiration dates. [21 C.F.R. § 211.166(a)]

a.    Your firm does not have a written testing program to assess stability characteristics of your drug product, STRONG WOO LOK GAO.  In addition, your stability procedure (SMP-QC-01600) designed for new products is still a draft and not reviewed and approved by your QCU.

b.    Your firm has not conducted any stability studies for STRONG WOO LOK GAO.  Your firm accepted and relied on the expiration date provided by your plaster manufacturer.

c.    Your QCU did not adequately ensure that the drug products released to the market were supported by appropriate stability data.

In your response to this letter, provide documentation to support the current expiration dates assigned to your drug products currently in U.S. distribution, as well as a commitment to ensure that each of your drug products is routinely tested according to a stability program that has been approved by your QCU.

5.    Written procedures are lacking that describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, rejection of components, drug product containers, and closures.  Bagged or boxed components of drug product containers and closures are not stored off the floor and are not suitably spaced to allow cleaning and inspection. [21 C.F.R. § 211.80 (a) and (c)]

a.    Your written procedure “Material Receipt Management Procedures” (document#RM-02) has been in draft for two (2) years and never approved by your QCU.  In addition, this procedure only requires an examination of the purchase order for correctness and verification that the components are not damaged.

b.    Our investigator found that many boxes are stored on the floor in the warehouse.  Your warehouse was not able to provide adequate space to allow cleaning and inspection.

In response to this letter, provide a detailed corrective action plan for the receipt, sampling, testing, and release or rejection of drug components, containers, and closures.

6.    Your firm has not conducted at least one specific identity test and has not established the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals [21 C.F.R. § 211.84 (d) (1)]

a.    Our investigator found that your firm did not perform identity testing of incoming materials, instead only microbiological testing was performed.

In response to this letter, provide a detailed corrective action plan to address this deficiency.

7.    Your firm failed to ensure that employees received training in current good manufacturing practices, as well as in particular operations assigned to the employees [21 C.F.R. § 211.25(a)].

a.    The inspection documented that your firm lacks a training program and that none of your employees has received CGMP training.

In your response to this letter, provide a plan to develop an ongoing and robust CGMP training program for your personnel, including an explanation of how you will assess training effectiveness.

UNAPPROVED AND MISBRANDED OVER-THE-COUNTER (OTC) DRUGS

In addition to the CGMP violations, your firm manufactures and/or distributes STRONG WOO LOK GAO. Based on the labeling statements for this product, STRONG OO LOK GAO is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)], because it is intended for use in the prevention, mitigation, treatment, or cure of disease, and/or intended to affect the structure or any function of the body. Examples of labeling statements documenting the intended uses of your product include, but are not limited to, the following:

• “For temporary relieve (sic) of pains, sprains, injuries, sore shoulders and backs, lumbago and pains in sinews and bones”
  

Ingredients declared on product label:

• “Active Ingredients: . . . Semen momordicae 1.5% . . . Semen Ricini 5% . . . Myrrha 2% . . . Olibanum 2% . . . Mentholum 5% . . . Methyl Salicylate 1%”
  

STRONG WOO LOK GAO is a “new drug,” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)], because this product is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505 of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your distribution of the above-mentioned product without an approved application violates these provisions of the Act.

We note, drug products intended for topical administration for OTC indications related to pain are being evaluated under the OTC Drug Review. The Tentative Final Monograph (TFM) issued on February 8, 1983, for OTC External Analgesics (48 FR 5852) is part of this evaluation. STRONG WOO LOK GAO is not covered under this TFM because its formulation includes the active ingredients “semen momordicae,” “semen ricini,” “myrrha,” “olibanum,” and “mentholum,” none of which are included in the OTC Drug Review for any indication. In addition, “bone” pain is not included in the external analgesic TFM. Thus, STRONG WOO LOK GAO is not eligible for inclusion in the OTC Drug Review.

On April 5, 2012 a Warning Letter (#300-12-007) was issued for failing to register and list as required under 21 CFR Part 207.40. Please include in your response the steps taken to comply with this requirement.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.  

Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, your failure to correct these violations may result in FDA refusing admission of articles manufactured at, Peking Medicine manufactory, Unit B, 7/F, Phase 1, Leader Industrial Centre, 188-202 Texaco Road, Tsuen Wan, New Territories, Hong Kong SAR, into the United States under Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the drug product(s) at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3004186759.

Please send your reply to the following address:

Yanyan (Jenny) Qin
Senior Policy Advisor
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 4235
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel:     (301) 796-3207
Fax:     (301) 847-8741

                                                                       
Sincerely,
/S/
Richard L. Friedman
Acting Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

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Page Last Updated: 04/08/2013

冰城

谁翻译的啊？哈哈，不过FDA人家确实很严谨

飞翔的草头香

一切需谨慎对待，别坏了国人身体！

JL052

最近FDA警告信特别多呀  

cph2345

这才是为了百姓的用药安全负责呀。向FDA的国外同行学习。

Killer

FDA是为消费者服务 GMP是为企业服务

naro520

企业也确实该反省下，不能只看着眼前的利益。