【先禁令后警告】江苏宝应县富康医疗器械公司遭FDA封杀
医疗人咖啡查询发现来自江苏的宝应县富康医疗器械公司已于9月20日被纳入FDA进口禁令#66-40。此次检查的检察官来自FDA CDER，检查依据FDA QSR 210&211进行。此次发布的警告信揭示了检查过程中发现的缺陷。
江苏宝应县富康医疗器械有限公司是1998年建立的一个专业生产医疗器械的企业。主要产品为医用棉球、医用棉条、医用棉签、医用纱布、绷带、口罩、帽和一次性卫生用品、医用棉签机、医用绷带机、医用棉球机、医用纱布切割机、针头冲冼磨三用机。
翻译来自：蒲公英 Julia朱玉姣
ViaUPS
Warning Letter 320-17-09
Return Receipt Requested
December 8, 2016
Mr. Yikai Fu
General Manager
Baoying County Fukang Medical Appliance Co., Ltd.
Guangyang Road
Huangcheng Town Industrial Area
Baoying County, Jiangsu Province
225800 China
Dear Mr. Fu:
The U.S. Food and Drug Administration (FDA) inspected your drugmanufacturing facility, Baoying County Fukang Medical Appliance Co., at SuzhongTrade of City Private Industrial Park, Baoying County, Yangzhou City, JiangsuProvince, from June 6 to 9, 2016.
FDA在2016年6月6-9日检查了你们在江苏扬州的生产场所。
Our investigators documented that your firm limited and/or refused an FDAinspection. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act),as amended by the Food and Drug Administration Safety and Innovation Act(FDASIA), section 707, 21 U.S.C. 351(j), your drug products are adulterated inthat they have been manufactured, processed, packed, or held in an establishmentwhere the owner or operator has limited inspection and refused inspection.
我们的检查人员记录了你们公司限制和/或拒绝FDA检查的情况。根据FD&C法案及FDASI法案， 由于你们生产、加工、包装和保存的设施所有者或操作人员限制和拒绝检查，你们的药品根据FDCA的定义被认为是掺假药品。
Our investigators also documented that your methods, facilities, orcontrols for manufacturing, processing, packing, or holding do not conform toC. Therefore your drug products are also adulterated within the meaning ofsection 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&CAct), 21 U.S.C. 351(a)(2)(B).
我们的检查人员还记录了你们的生产、加工、包装和保存方法、设施或控制不符合CGMP要求，因此你们的药品根据FD&C法案21 U.S.C. 351(a)(2)(B)第501(a)(2)(B)部分定义被认定为掺假药品。
On June 6, 2016, you signed a “declaration” saying you would (b)(4),and on June 8, 2016, you signed a “declaration” saying that your firm would (b)(4).We have not received a response from your firm for corrective actions to theviolations identified during the inspection.
你们在2016年6月6日签署的一份“声明“中说你们会XX，而在2016年6月8日，你们签署了一份”声明“说你们公司会YYY。我们没有收到你们公司发来的针对检查期间发现的违规情况的纠正措施。
This warning letter summarizes your limitation of an inspection andsignificant deviations from CGMP for drug manufacturing. Our investigatorsobserved specific deviations including, but not limited to, the following.
本缺陷信总结了你们限制检查以及药品生产违反CGMP的情况。我们的调查人员发现的违规情况包括但不仅限于以下：
1. Your firm delayed, denied, or limited an inspection,or refused to permit the FDA inspection.
你们公司延迟、拒绝或限制检查，或拒绝FDA检查要求。
On June 6, 2016, during the inspectional walk through of the laboratorytesting area of your facility, our investigator asked you to explain themicrobiological testing processes used on the (b)(4) that youmanufacture and distribute to the United States. Your firm’s representativestated he would not disclose the firm’s trade secrets. Our investigatorexplained that as part of the inspection, FDA needs to know the details of theoperations, and that FDA does not disclose details of the information. Nonetheless,without reasonable explanation, the full test procedure was never provided.
在2016年6月6日，在检查人员巡查化验室检验区域时，我们的检查人员要求你们解释你们生产和销往美国的XX产品所用的微生物检测过程。你们公司的代表声称他不会泄露公司的商业机密。我们的调查人员解释说作为检查的一部分，FDA需要知晓操作的细节，FDA并不会披露详细信息。但是，在没有合理解释的情况下，你们一直不肯提供完整的检测程序。
Your firm limited the inspection by refusing to disclose the manufacturingprocess you use in your facility to conduct microbiological testing on (b)(4).You may wish to review FDA’s guidance document, Circumstances thatConstitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,at
你们公司拒绝透露你们工厂用于XX的微生物检测的生产工艺。你们可能需要参与上述指南。
2. Your firm failed to establish an adequate qualitycontrol unit with the responsibility and authority to approve or reject allcomponents, drug product containers, closures, in-process materials, packagingmaterial, labeling, and drug products. (21 CFR211.22(a))
你们公司未能建立充分的质量控制部门，具备授权职责来批准或拒绝所有部件、药用容器、密闭器、中控物料、包材、标签和药品。(21 CFR 211.22(a))
During the investigation, our investigator found your firm has no writtenprocedures for production or quality unit responsibilities. Among other things,your quality unit approved and released (b)(4) and (b)(4) fordistribution to the U.S. market. Your firm approved these products for releaseeven though your quality unit had no assurance that they met specifications orthat they were manufactured under adequate controls.
在检查期间，我们调查人员发现你们公司没有书面的生产和质量部门职责程序。其中，你们质量部门批准和放行XX和YY销售至美国市场。你们公司批准这些产品放行时，你们的质量部门甚至不能确保他们符合质量标准，不能保证这些产品的生产受到充分的控制。
3. Your firm does not have, for each batch of drugproduct, appropriate laboratory determination of satisfactory conformance tofinal specifications for the drug product, including the identity and strengthof each active ingredient, prior to release. (21 CFR 211.165(a))
你们公司没有在放行前对每批产品进行适当的化验室检测，保证其令人满意地符合药品的最终质量标准，包括每种活性成分的鉴别和浓度。(21 CFR 211.165(a))
Your firm manufactures (b)(4) labelled “For (b)(4).” Yourfirm stated to the investigator that you do not perform microbiologicalanalysis of your final products prior to release to the U.S. market. Inaddition, you informed our investigator that you do not perform assay testingfor your over-the-counter (OTC) drug products to verify the identity andstrength of the active ingredients prior to release. Your firm also failed toprovide requested records for chemical analyses performed for products releasedto the U.S. market.
你们公司生的XX标示为”XX专用”。你们公司向调查人员声称你们在将最终产品放行至美国市场之前并没有进行微生物分析。此外，你们通知我们调查人员，你们在放行之前没有对你们的OTC药品进行含量检测，以查验活性成分的种类和浓度。你们公司还无法提供检查人员要求查看的产品放行至美国市场所做的化学分析记录。
4. Your firm failed to maintain the buildings used in themanufacture, processing, packing, or holding of a drug product in a clean andsanitary condition and to keep them free of infestation by rodents, birds,insects, and other vermin. (21 CFR 211.56(a))
你们公司未能维护药品生产、加工、包装和存贮所用的建筑物的清洁卫生，保持其不受虫鼠、鸟儿、昆虫和其它害虫的侵害。(21 CFR 211.56(a))
Our investigator documented copious amounts of unknown black, mold-likematerial on the floor and walls of warehouse #2. In addition, our investigatorobserved standing water on the floor and live insects at the entrance of thesame warehouse. This warehouse is a storage area for (b)(4) used in theproduction of your firm’s (b)(4). The poor conditions in your facilitycould compromise the quality of the products you manufacture.
我们的调查人员记录了在2号仓库的地板和墙面上有大量未知黑色、貌似霉菌物料，我们调查人员发现地板上有积水，在同一仓库里的入口处有活的昆虫。此仓库是你们公司XX生产所用的YY的存贮区域。你们设施这么差的条件可能会导致你们生产的药品质量问题。
5. Your firm failed to provide adequate washingfacilities, including hot and cold water, soap or detergent, air driers orsingle service towels, and clean toilet facilities easily accessible to workingareas. (21 CFR 211.52)
你们公司未能提供充分的洗浴设施，包括冷水和热水、肥皂或清洁剂、热风机或一次性毛巾，以及清洁的厕所，让工作区域的人员易于进出。
There was no adequate washing facility accessible to working areas at yoursite. Additionally, the only toilet facility on-site contained visible sewageand had no running water. This toilet facility is shared by production,quality, and administrative personnel at your facility.
你们工厂工作区域没有易于进出的充分洗浴设施。此外，工厂唯一的一个厕所里面有明沟，水是不流动的。此厕所设施是你们生产、质量和行政人员共用的。
6. Your firm failed to establish and follow writtenprocedures describing in sufficient detail the receipt, identification,storage, handling, sampling, testing, and approval or rejection of componentsand drug product containers and closures. (21 CFR 211.80(a))
你们公司未能建立和遵守详细描述部件和药品容器密闭器的接收、鉴别、存贮、处理、取样、检测和批准/拒收书面程序。(21 CFR 211.80(a))
Specifically, your firm receives drums of (b)(4) raw material fromyour supplier without any identifying labels. Your firm does not performidentity testing or any other analysis onincoming raw materials upon receipt orprior to use, and you have no procedure that permits you to trace the source ofthe (b)(4) in each batch of finished products.
具体情况是你们公司收到你们供应商送来的桶装原料，但没有任何识别标签。你们公司在接收时或使用该物料之前没有进行鉴别测试，也没有进行其它的的进厂物料检测，你们也并没有程序能够追溯每批成品中所用原料的来源。
Conclusion 结论
Violations cited in this letter are not intended as an all-inclusive list.You are responsible for investigating these violations, for determining thecauses, for preventing their recurrence, and for preventing other violations.
本函中所引的违规行为并不是全部清单。你们有责任调查这些违规情况，确定其原因，并防止其再次发生，防止其它违规行为。
FDA placed your firm, located at Suzhong Trade of City Private IndustrialPark, Baoying County, Yangzhou City, Jiangsu Province, on Import Alerts 66-40and 99-32 on September 20, 2016.
FDA已于2016年9月20日将你公司发布在进口禁令66-40和99-32清单中。
Until you correct all violations completely and we confirm your compliancewith CGMP, FDA may withhold approval of any new applications or supplementslisting your firm as a drug manufacturer.
在你们完全纠正所有违规情况，我们确认你们符合CGMP之前，FDA可能会暂停将你们公司列为药品生产商的所有新申报和增补。
Failure to correct these violations may also result in FDA continuing torefuse admission of articles manufactured at Baoying County Fukang MedicalAppliance Co., Suzhong Trade of City Private Industrial Park, into the UnitedStates under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Underthe same authority, articles may be subject to refusal of admission, in thatthe methods and controls used in their manufacture do not appear to conform toCGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C.351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15working days. Specify what you have done since our inspection to correct yourviolations and to prevent their recurrence. If you cannot complete correctiveactions within 15 working days, state your reasons for delay and your schedulefor completion.
Send your electronic replyto or mail your reply to:
Carla A. Norris, Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Please identify your response with FEI 3006795842.
Sincerely,
/S/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research