FDA警告信-常州千红生化制药有限公司

巴西木

FDA警告信-常州千红生化制药有限公司

常州千红生化制药有限公司13年6月4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

WL：300-12 - 16

2013年6月4日

王耀方先生
常州千红生化制药有限公司
新北区黄河西路192号
，江苏省常州市，中国213032
飞：3005275502

尊敬的王先生：

美国食品和药物管理局（FDA）已审阅有关药物进入美国的出货量从上面列出的建立条目，以及关于建立药品注册和上市的有关文件。该项研究显示，你有没有履行注册义务根据“联邦食品，药品和化妆品法案”（该法案）。我们的记录显示你已经准备生产，传播，复合，或处理药物被进口或进口到美国的过程中你没有登记时间。

根据第510（I）（1）法“（21 USC§360（I）（1）），则需要每年最初提交注册信息，从10月1日至12月31日期间，以电子方式为每个外国机构拥有或经营，是一家从事生产，配制，传播，私了，或进口或进口到美国的药物处理。未能按照本规定注册，是一个禁止的行为，根据该法第301（P）（21 USC§331（P））。  

此外，提供进口的药物可能被拒绝入场，根据第801（A）（3）的法令（21 USC§381（A）（3）），如果药物似乎是掺假或伪造。根据第502（O）法“（21 USC§352（O）），第510条所规定的注册成立，列出第510（j）条所规定的药物，或提供一定的通知或信息的故障关于第510条规定的药物，使药物冒牌。FDA规定21 CFR第207指定药品注册和上市的要求。

为了纠正上述违反该法，并确保您的药物不受美国拒绝接纳上述确定的基准，你应该立即采取行动，在新北区黄河西路192号设立登记区，江苏省常州市，中国213032 ，并确保您已经正确地上市的药品提供进口到美国制造。

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纠正这种违反该法的行为所采取的行动。如果你打算继续生产药品，进口或进口到美国的，你必须完成所需登记和上市。在这种情况下，请告知您已经履行这些要求，在回应这封信。如果你不能完成必要的纠正措施后十五个营业日内，说明延迟的原因和日期，你会完成校正。如果你不是打算停止生产的药物，正在进口或进口到美国的这一意图，请通知我们，并提供生产这些药物的终止通知，根据第510（J）（2）法“（21 USC§360（J）（2））和21 CFR Part 207。请直接对应：

多诺万楼杜根
药品评价和研究中心/合规办公室
白橡，51号楼，2260室
新罕布什尔州大道10903号
电话：（301）796-3100
传真：（301）847-8747
edrls@fda.hhs.gov

美国FDA不再接受提交论文登记及上市。设立登记应当提交信息或更新使用新的电子系统通过结构性产品标签（SPL）。信息如何使用电子系统，请访问：http://www.fda.gov/eDRLS

真诚的，
/ /
道格拉斯·斯特恩
政策和分析的副主任
合规办公室
药品评价和研究中心

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关闭输出信

• 常州千红生化制药有限公司 - 信13年7月9日关闭
  

常州千红生化制药有限公司 - 信13年7月9日关闭

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

2013年7月9日

王耀方先生
常州千红生化制药有限公司
编号 192，黄河西路，
江苏省常州市新北区，中国213032
号码：3005275502

尊敬的王先生，

美国食品和药物管理局已经完成了贵公司的整改行动响应我们的警告信＃300-12-16日期为2013年6月4日的评估。基于对我们的评价，看来，你已经解决了冲突（）包含在该警告信。未来美国FDA检查和监管活动将进一步评估这些修正的充足性和可持续性。

这封信并不免除您或您的公司的责任，采取一切必要的步骤，以确保持续符合联邦食品，药品和化妆品法“及其实施条例规定，或与其他相关的法律权威。该机构预计，你和你的公司保持合规性，并会继续密切留意你的合规状态。这封信将不排除任何未来的监管行动，应该观察在随后的检查，或通过其他手段侵犯。

真诚的，

/ S /

道格拉斯·斯特恩遵守药物评价和研究中心的
政策和分析
办公室副主任

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最后更新：2013年7月17日

Changzhou Qianhong Bio-Pharma Co., Ltd 6/4/13

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

Warning Letter

WL: 300-12- 16

June 4, 2013

Mr. Yaofang Wang
Changzhou Qianhong Bio-Pharma Co., Ltd
No.192 Huanghe West Road, Xinbei District
Changzhou, Jiangsu, China 213032
FEI: 3005275502

Dear Mr. Wang:

The United States Food and Drug Administration (FDA) has reviewed entries regarding shipments of drugs into the United States from the establishment listed above, as well as information on file concerning your establishment’s drug registration and listing. This review revealed that you have not fulfilled your registration obligations under the Federal Food, Drug, and Cosmetic Act (the Act). Our records indicate you have manufactured prepared, propagated, compounded, or processed drugs that were being imported or offered for import into the United States during a time you were not registered.

Under section 510(i)(1) of the Act (21 U.S.C. § 360(i)(1)), you are required to submit registration information initially annually, during the period from October 1 through December 31, by electronic means for each foreign establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States. The failure to register in accordance with this provision is a prohibited act under section 301(p) of the Act (21 U.S.C.§ 331(p)).  

In addition, a drug offered for import may be refused admission under section 801(a)(3) of the Act (21 U.S.C. § 381(a)(3)), if the drug appears to be adulterated or misbranded. Under section 502(o) of the Act (21 U.S.C. § 352(o)), the failure to register an establishment as required by  section 510, to list a drug as required under section 510(j) or to supply certain notice or information about the drug required under section 510, renders a drug misbranded. FDA regulations in 21 CFR part 207 specify the requirements for registering and listing drugs.

To remedy the above-mentioned violation of the Act and ensure that your drugs are not subject to refusal of admission to the United States on the bases identified above, you should take action immediately to register the establishment at No.192 Huanghe West Road, Xinbei District Changzhou, Jiangsu, China 213032, and ensure that you have properly listed drugs being offered for import to the United States that are manufactured there.

Within fifteen working days of receipt of this letter, please notify this office in writing of the actions taken to correct this violation of the Act. If you intend to continue to produce drugs that are being imported or offered for import into the United States, you must complete the required registration and listing. In such case, please inform us that you have fulfilled these requirements in response to this letter. If you cannot complete the required corrective action within fifteen business days, state the reason for the delay and the date by which you will have completed the correction. If you instead intend to cease producing drugs that are being imported or offered for import into the United States, please notify us of this intent and provide notice of discontinuance of production of those drugs in accordance with section 510(j)(2) of the Act (21 U.S.C. § 360(j)(2)) and 21 CFR part 207. Please direct correspondence to:

Donovan F. Duggan
Center for Drug Evaluation and Research/Office of Compliance
White Oak, Building 51, Rm 2260
10903 New Hampshire Ave
Tel:     (301) 796-3100
Fax:    (301) 847-8747
edrls@fda.hhs.gov

FDA no longer accepts paper submissions for Registration and Listing. Establishment registration information or renewal should be submitted via Structured Product Labeling (SPL) using the new electronic system. For information on how to use the electronic system visit: http://www.fda.gov/eDRLS

Sincerely,
/s/
Douglas Stearn
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research
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Close Out Letter

• Changzhou Qianhong Bio-Pharma Co., Ltd - Close Out Letter 7/9/13
  

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Page Last Updated: 07/17/2013

Changzhou Qianhong Bio-Pharma Co., Ltd - Close Out Letter 7/9/13

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

July 9, 2013

Mr. Yaofang Wang
Changzhou Qianhong Bio-Pharma Co., Ltd.
No. 192, Huanghe West Road, Xinbei District
Changzhou, Jiangsu, China 213032
FEI: 3005275502

Dear Mr. Wang,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 300-12-16 dated June 4, 2013. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,

/S/

Douglas Stearn
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research

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Page Last Updated: 07/17/2013

wangjin1023

这是一个不好的信息

男儿当自强

有意思啊。。。