【奥译言】CDRH和CDER向六家亚洲企业发出警告信
关注奥咨达公众号
继2016年9月的警告信风波之后，美国食品药品监督管理局（FDA）继续向中国、印度、台湾和日本的六家制药和医疗器械企业发出了六封新的警告信。
最近的一封警告信是美国FDA药品评价与研究中心（CDER）于2017年2月3日向印度的一家活性药物成分（API）制造商（Resonance Laboratories Private Limited）发出的，2016年5月，对该制造商进行了为期四天的检查之后，检查人员发现该制造商不能证明其供水系统适用于清洗设备。
警告信指出，在获得不合格的清洁验证结果后，该制造商进行了反复清洗，直到获得合格的验证结果。该制造商并未对反复出现的清洁程序无效性进行调查，也没有对缺陷程序进行修复。
另一封警告信是CDER于2017年2月2日向日本的制造商（Sato Pharmaceutical Co., Ltd.）发出的，警告该制造商违反了与监测无菌加工区环境条件有关的规定，以及该制造商未能在“静止”和“动态”条件下进行烟气研究以评估其开放式限制进出隔离系统的空气流通特性。
FDA建议Sato聘请一位专业咨询师，协助其满足CGMP的要求。
另一封警告信是CDER于2017年1月26日向中国的制造商（浙江邦立医药用品有限公司）发出的，警告该制造商没有对来料的活性药物成分或用于制造贴片的其它组分进行检测以确定其特性、纯度和效力。
FDA实验室分析还显示，该公司产品的样品对标示的活性成分效力差，其平均效力仅为标示声称的69.0％。
另一家中国制造商（澳思美日用化工（广州）有限公司）于2017年1月31日收到了CDER发出的警告信，警告该制造商只测试了2015年放行的三个批次产品的特性和强度以及两个批次产品的微生物质量。
警告信还指出，澳思美日用化工（广州）有限公司仅根据活性原料的外观和气味来决定是否接受并在其药物产品中使用这些活性原料。
2016年10月4日，台湾的一家血糖仪制造商（Broadmaster Biotech Corp.）收到了FDA医疗器械与放射健康中心（CDRH）发出的警告信，调查人员发现，从2016年1月至2016年4月收到的233份投诉中，有86份是由于该制造商没有定期检查和评价而造成的问题代码。
CDRH还于2016年9月15日向中国的湖北宏康防护用品有限公司发出了警告信，该制造商未能允许FDA完成检查。
CDRH and CDER Send Warning Letters to Six Asian Companies
Posted 14 February 2017 By Zachary Brennan
The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.
The most recent letter, sent from FDA’s Center for Drug Evaluation and Research (CDER) to Bangalore, India-based active pharmaceutical ingredient (API) manufacturer Resonance Laboratories on 3 February, following a four-day inspection last May, says investigators found that the company had failed to demonstrate that its water system is suitable for cleaning equipment.
“After obtaining failing cleaning verification results, you repeated cleaning until you obtained passing verification results,” the letter says. “Your firm failed to investigate recurring cleaning procedure ineffectiveness and did not remediate the deficient procedures.”
Another warning sent to Japan-based Sato Pharmaceutical on 2 February includes violations related to monitoring environmental conditions in the site’s aseptic processing areas, as well as its failure to perform smoke studies under “at rest” and “dynamic” conditions to evaluate air flow characteristics of its open Restricted Access Barrier System.
FDA recommends that Sato engage with a consultant to assist it in meeting CGMP requirements.
Another warning letter sent by CDER to China-based Zhejiang Bangli Medical Products Co. on 26 January included violations for failing to test incoming active pharmaceutical ingredients or other components used in manufacturing patches to determine their identity, purity and potency.
FDA laboratory analysis also showed that samples of the company’s product “were sub-potent for the labeled active ingredient, containing an average potency of 69.0% of the label claim.”
Similarly, China-based Ausmetics Daily Chemicals received a warning letter sent 31 January with violations including the fact that the firm only tested three batches released in 2015 for identity and strength, and two batches for microbiological quality.
Ausmetics also “accepted and used active raw materials in your drug products based only on their appearance and odor,” the letter says.
Taiwan-based blood glucose meter manufacturer Broadmaster Biotech received a Center for Devices and Radiological Health (CDRH) warning letter sent 4 October 2016 after investigators found that of 233 complaints received from January 2016 through April 2016, 86 were for issue codes that the firm does not routinely review and evaluate.
CDRH also sent a warning letter to China-based Hubei Hongkang Protective Products Co. on 15 September for failing to allow FDA to complete its inspection.
内容来自：RAPS
整理翻译：奥咨达
奥咨达翻译团队根植于中国，面向全球，专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等，译稿已涵盖医疗器械领域的所有类型。
奥咨达翻译组联系方式：
邮箱：trans@osmundacn.com
Q Q：2761773878 （昵称：OSD_trans）
热点推荐
可点击标题阅读原文