禁止从印度主要生产商进口
2015-10-23 Medicn

Posted 15 October 2015

The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US.
美国FDA在周五增加印度原料药生产商Megafine药业加进了禁止销售产品进入美国市场的外国生产商名单。

Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market, including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and overactive bladders. The company also produces the same number of APIs for the EU market, as well as a number of other products for Canada, Australia, Brazil, Mexico and South Korea. The Nashik site, according to the company, has been inspected and approved by regulators including the European Medicines Agency, Japan's Pharmaceutical and Medical Devices Agency, the WHO and others.
Megafine，在5月已经收到了FDA现场的483表，为美国生产24种原料药，包括旨在治疗阿尔茨海默氏症、抑郁症、精神分裂症、多发性硬化症和膀胱过动症。公司也欧盟市场生产同样数量的原料药，也为加拿大、澳大利亚、巴西、墨西哥和南韩生产一定数量的其他产品。该公司Nashik场地已经接受并被包括欧盟、日本、WHO和其他多个官方机构批准。

The notice on Megafine does not indicate the specific issues that caused the import alert and does not indicate if the company's other manufacturing site in Vapi, India will be impacted.
对Magafine的通知没有显示引起进口警告的特别问题也没有显示该公司在印度Vapi的其他生产场地是否被影响。

Form 483 FDA

According to a heavily redacted 13-page Form 483, the company was cited for manipulating lab tests, as well as unjustified and unrecorded deviations from written lab mechanisms. The 483 notes that one of the company's quality control (QC) analysts "manipulated" a test chromatogram "by removing the unwanted peak out of the chromatogram and passed off the passing chromatogram as the valid result."
按照经过修订的多达13页的483表，该公司伪造了试验室测试以及未证明和未记录书面的实验室机制的偏差。483表注意到该公司一个QC分析员“通过去删除色谱图中不想要的色谱峰并将该色谱作为合法的结果”“伪造”一个测试色谱图。

In addition, the FDA inspector found that the QC management could not explain the "wide variation between" an initial test result and a retest result, though, “It is believed that the initial OOS [out of specification] assay was switched with old passing sample vials and retested to obtain the passing test results."
另外，FDA检查员还发现QC管理不能解释初始测试结果和重新测试结果之间的“很大差异”，不过，“相信初始的OOS（超标）含量已经用老的放行的样品进样替换了并重新测试得到了通过的测试结果”。

Another QC analyst was cited for manipulating high-performance liquid chromatography software "to obtain passing test results."
另一个QC分析员被发现伪造了HPLC色谱软件“以获得一个通过的测试结果”。

In addition, FDA found that no "investigation reports were initiated after identification of non-cGMP [current good manufacturing practice] practices within the production and quality control department."
另外，FDA还发现“在生产和QC部门发现了非cGMP行为后没有调查报告”。

Companies on the import alert list that would like to request removal, according to FDA, "should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation."
想要在进口警告清单中去除的公司按照FDA”应该向FDA提供信息充分证明生产商已经解决了导致违规行为出现的条件以便官方相信未来进入将是合规的。这可能包括一封详细描述纠正措施并附有文件的申请信。

Forty-five other Indian pharmaceutical and API manufacturers are currently included on the import alert list, including Ranbaxy, Wockhardt and Ipca Laboratories.
45家其他印度的药品和原料药生产商目前已经在进口警告清单中，包括Ranbaxy、Wockhardt和PCA。

Megafine did not respond to a request for comment.
Megafine没有对评论做出反馈。