印度CRO状告FDA,HHS,美国以及其他个人，并索赔5000万美元

beiwei5du

印度CRO企业Semler Research Center (SRC) 被FDA检查不合规后，导致丢掉客户，面临客户赔偿，从而状告FDA,HHS,美国以及其他个人，并索赔5000万美元

‘Ostracized and criticized’ Indian CRO hits US FDA with $50m lawsuit

29-Jan-2018

By Dan Stanton

In April 2016, the US Food and Drug Administration (FDA) issued Semler Research Center (SRC) an ‘Untitled Letter’​ stating evidence it had found of data manipulation in a number of bioanalytical studies during an inspection of its facility in Bangalore, India in September and October 2015.

The Agency then sent a notice​ to drug sponsors that bioavailability/bioequivalence (BA/BE) studies conducted by the contract research organisation (CRO) would need to be repeated.

$50m lawsuit​

But last week Semler filed a lawsuit against the FDA, the United States Department Of Health And Human Services (HHS) and the United States Of America – along with various individuals – for total damages of approximately $50m (出现故障，后面无法粘贴）

https://www.in-pharmatechnologist.com/Article/2018/01/29/Ostracized-and-criticized-Indian-CRO-hits-US-FDA-with-50m-lawsuit?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

beiwei5du

Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Semler Research Are Unacceptable

[4/20/2016] FDA is notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Semler Research Private Limited (Semler) located in Bangalore, India, are not acceptable as a result of data integrity concerns, and need to be repeated. Semler is a contract research organization that conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies.

FDA is taking this action as a result of an inspection of Semler’s bioanalytical facility in Bangalore, India, conducted between September 29, 2015, and October 9, 2015. The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples. Yesterday, FDA issued an “Untitled Letter” to Semler detailing our findings related to the facility. A copy of this letter is available below.

FDA has evaluated drugs that were approved based on data from Semler that supported approval during the regulatory review process. FDA has conducted a thorough review of postmarket serious adverse events for all drug products which had studies conducted at Semler facilities. To date, the agency has not identified reports that raise serious safety concerns with these products. However, FDA is requiring that sponsors of approved applications repeat the bioequivalence/bioavailability studies using an entity other than Semler. FDA is also changing the therapeutic equivalence (TE) rating in FDA’s Approved Drug Product with Therapeutic Equivalence Evaluations (the Orange Book) for any approved ANDA that relied on data from Semler to “BX.” A BX rating indicates that data reviewed by the agency are insufficient to determine therapeutic equivalence, i.e., substitutability, of the generic product to the drug it references.

FDA is sending letters to sponsors of applications that are currently under review that include data from studies conducted at Semler. The letter informs the sponsor that it must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an acceptable alternate study site.

Affected sponsors are encouraged to review the documents below, and contact the relevant FDA review division in the Office of Generic Drugs or the Office of New Drugs for further information.

syhorchid

印度SRC，真牛！

zysx01234

被FDA检查不合规后，导致丢掉客户，面临客户赔偿，从而状告FDA,HHS,美国以及其他个人，并索赔5000万美元——厉害佩服

Jacob1188

三哥终于硬了。。一回。。

志超

不愧是三哥，牛

牧童摇指

这就很厉害了，毕竟三哥。

beiwei5du

zysx01234 发表于 2018-1-30 09:16
被FDA检查不合规后，导致丢掉客户，面临客户赔偿，从而状告FDA,HHS,美国以及其他个人，并索赔5000万美元— ...

1、The firm claims the FDA’s actions were in violation of the Fifth Amendment, interfered with economic advantages and intentionally inflicted financial distress on the company.
2、The plaintiff claims the defendants did this with the “intent of eliminating SRC from the marketplace to the benefit of other CROs,”​ especially those based in the US and those based in India “with whom FDA Inspectors had personal relationship with the owners or employees.”​

云卷云舒0415

阿三的世界，不是一般人能懂的

北重楼

胆子蛮大的

aaronchia

三哥威武

胜利者

帮三世界顶起

beiwei5du

A Rogue CRO Employee, a Suspect Spreadsheet, and now a $50m Lawsuit Against FDA

Posted 29 January 2018 | By Zachary Brennan

Back in April 2016, the US Food and Drug Administration (FDA) put out an alarming notification to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research "are not acceptable as a result of data integrity concerns."

FDA's notification created a domino effect whereby the World Health Organization (WHO) and the European Medicines Agency (EMA) also said they began investigations into and took action against Semler.

But now, Semler, while acknowledging the falsified data, is trying to explain what happened, how FDA built its case against the CRO, how other regulators blindly followed FDA, and why Semler is seeking $50 million in damages from the US agency, according to a lawsuit filed in the US District Court of the Central District of California earlier this month.

Semler's Perspective

On 29 September 2015, FDA inspectors launched the surprise 10-day inspection of the Bangalore facility involved with conducting bioequivalence (BE) and bioavailability (BA) studies, which Semler says FDA told them would be "to verify the computer validation and related aspects of BA/BE testing."

At the time of the inspection, Semler says FDA had already approved at least eight generic drugs for the US market and for which Semler had conducted the BA/BE study, a clinical study or both, and of these eight, Semler says FDA inspected one of its facilities six times.

During this surprise inspection, however, FDA uncovered an Excel spreadsheet that the company claims was "what they were looking for from the start," and the head of Semler's quality affairs department said she "had never seen it before, and would have to look into it."

So what was in this spreadsheet, which Semler refers to as "the Suspect Spreadsheet"?

The company says that back in 2015, while other Semler employees were at lunch, someone accessed the company's server, entered fabricated data in this spreadsheet and that the move was a deliberate undercutting of Semler as the employee was working with former Semler employees now working for an unnamed CRO competitor in Bangalore.

"In summary, the fabricated data set forth in the Suspect Spreadsheet was believed to have been created and placed on within [sic] the Suspect Spreadsheet by a rogue employee whom was acting in concert with a group of former employees of SRC [Semler] that were working for a competing CRO in Bangalore, India after the BA/BE head (and the person who started the new CRO) had parted ways with SRC," the lawsuit says.

On the basis of the spreadsheet, Semler claims that "FDA concluded there were serious inconsistencies in the research conducted by SRC and asked SRC to explain the reasons for the Suspect Spreadsheet and to justify that the information of the Suspect Spreadsheet is false."

But an independent audit, the results of which were sent to FDA in January 2016, "revealed no evidence of data manipulation and confirmed that all Standard Operating Procedures and study specific protocols were followed, and in the rare instance there was a deviation it was documented and explained and had no impact on the results of the study," Semler says in the lawsuit. "Further, it was again presented to FDA that the Suspect Spreadsheet was not representative of data tracking or collection by SRC, was not authorized or reflective of the results of the identified studies, and was believed to have been planted on SRC's server."

Regulators Take Action

But by April 2016, FDA sent an untitled letter to the company and then took action on informing companies relying on Semler and other regulators of what happened. The other regulators, meanwhile, saw FDA's action and followed suit.

WHO and EMA withdrew their respective prior approvals of generic pharmaceuticals whose studies had been conducted by Semler, though EMA left on the market generic drugs deemed necessary for the public despite Semler's work on the studies.

Semler also contends: "EMA never conducted any inspection but only relied on FDA's claims and April 19, 2016 letter to conclude adversely ... On the basis of the conclusions of WHO, EMA, and the FDA, several other countries' governing bodies regarding pharmaceutical testing, such as the Ministry of Health of Malaysia and the customers of SRC are rejecting the studies conducted by SRC and demanding compensation from SRC. These companies include, without limitation, Lupin Limited, Microlabs Limited, Dr. Reddy's Limited, and Inventia Healthcare Pvt Ltd.

"Further, while FDA's adverse observations were only in case of certain studies, other regulatory agencies have doubted the credibility of all the research that was conducted by Plaintiff, even though they were not a part of the studies with respect to which the FDA had doubts about credibility of the research, because FDA made a blanket determination that none of the research conducted by SRC was reliable," Semler says.

As a result of what Semler says are FDA actions taken without providing it "any due process, with the intent to inflict financial distress, with the intent to intentionally interfere with SRC's economic advantage, and without reasonable care and diligence" mean Semler could not be sold, which it claims was worth about $30 million, and further exposed the company to claims from former clients of $20 million.

FDA Form 483

FDA Untitled Letter

EMA

WHO

beiwei5du

一桩精心策划，有预谋有组织的老员工扳倒老东家的神奇案件啊！美国CIA应该介入调查！

beiwei5du

印度 CRO Semler 就数据可靠性问题起诉美国 FDA

2018-01-26 识林

印度合同研究机构（CRO） Semler 研究中心（SRC）于 1 月 22 日在美国加利福尼亚中区地区法院提交起诉书，起诉美国 FDA 公开 CRO 称之为莫须有的关于数据欺诈的声明的决定，破坏了其声誉并损害了其业务。Semler 在起诉中称，由于 FDA 2016 年 4 月关于申办人必须对于他们已获批的产品和未决申请重做由 SRC 开展的生物利用度和生物等效性（BA/BE）研究的公告，SRC 已经因利润损失和前客户潜在的索赔遭受了 5 千万美元的损失。

FDA 在现场检查对 SRC 生成的数据的有效性和可靠性提出重大疑虑之后采取了行动。有关 FDA 对 Semler 采取行动的详细情况，请参阅【FDA严处印度临床研究机构Semler 2016/04/22】

但是，SRC 的起诉称无效或伪造的研究数据并未提交给 FDA。相反，FDA 结论是基于一份显示包含捏造数据的“可疑电子表格”。起诉书称，该电子表格是由一名“无赖员工”与前雇员一起在公司的计算机服务器上恶意创建的。

起诉书称，“FDA 2016 年 4 月 20 日的通知和客户函以及其中的决定，即，拒绝并认为 SRC 的所有临床和生物分析都不可接受，而当时 SRC 的回复时间尚未结束，没有给 SRC 正名听证会或向公众的特别法庭提交证据的机会，剥夺了 SRC 的基本财产利益和自由利益……可能最重要的是其开展业务的能力以及其声誉利益。”起诉书称，FDA 行动的耻辱“导致 SRC 业务的完全毁坏，以及其基于被告行为而受到的客户钱财索赔的风险。”

起诉书根据《正当法律程序条款》（Due Process Clause）以及《联邦侵权索赔法》（Federal Tort Claims Act），主张故意施加财务困境，故意干涉经济利益和失职。被告包括 FDA 和卫生与人类服务部的负责人，以及八名 FDA 员工，其中四名参与了该公司设施的检查。

FDA 表示不会对未决诉讼发表评论。

下面我们来看看 Semler 在起诉书中对整个事件的描述。

FDA 检查发现可疑电子表格

起诉书表示，CRO 在 2015 年 10 月之前有着模范的合规记录，之前仅有一份 FDA 483。2015 年 9 月 29 日，FDA 工作人员对位于印度班加罗尔的 SRC BA/BE设施和公司办公室进行了突击检查。根据起诉书，检查人员告诉 SRC，检查的目的是核实计算机验证和 BA/BE 测试的相关方面。

“FDA 检查员检查了 BA/BE 设施的所有不同区域，包括但不限于，仪器区域、血液样品贮存室……以及计算机服务器机房。FDA 检查员还检查了与 LCMS 仪器（用于处理和检测 BA/BE 研究血液样品的机器）相连的计算机系统，对这些系统的访问控制，以及与这些仪器（仪器计算机）相连的硬盘上的数据文件。”

SRC 向FDA 检查员提供了对其中一台仪器计算机以及对一台架设在会议内的 SRC 笔记本电脑的访问权限。“FDA 检查员多次前往 BA/BE 仪器室检查与仪器相连的仪器计算机系统，并将其与在会议室的用笔记本电脑的访问进行比较。SRC 笔记本电脑无法访问仪器计算机访问的内容，因为 SRC 笔记本电脑没有 BA/BE 分析员用于登录笔记本电脑的用户名和密码。”

检查员使用一部 FDA 平板电脑对仪器计算机上列出的文件夹拍照，并试图将这些文件夹与会议室笔记本电脑上提供的文件夹相匹配。一名 SRC 员工看到其中一位检查员正在查看平板电脑上的图片，图片显示文件资源管理器窗口打开了“Y”服务器，文档路径通向名为“DUMP”的文件夹。在查看该照片后，检查员再次搜索仪器计算机，访问 SRC 服务器上的一份电子表格文件，拍摄了该文件的一部分内容并要求提供打印版。“FDA 检查员似乎找到了他们从一开始就想要的东西，此后立即询问了 SRC 的 QA 部门主管，问她是否知道可疑电子表格是什么，她回答说不知道，从未见过这份表格，必须先查看一下。”

这份电子表格“包含声称证明 2011 年至 2014 年间由 SRC 执行的五个不同研究的研究数据操纵的信息。”根据与起诉书一起提交的电子表格的副本，这些研究包含两个乙酰唑胺、一个阿扎那韦、一个塞来昔布和一个沙奎那韦研究。

公司着手内部调查

SRC 表示，公司立即开始调查该电子表格，以及表格是如何进入公司服务器的。“可疑电子表格中的伪造数据被认为是由一名无赖员工与一群 SRC 前雇员协同作案创建并放置在可疑电子表格中的，这些 SRC 前雇员当时正在印度班加罗尔的一家竞争对手 CRO 中工作，这家竞争对手的 BA/BE 负责人在与 SRC 分道扬镳后开设了新的 CRO。”

起诉书中的一个脚注指出，SRC 在印度提起了一项刑事诉讼，“针对那些被认为采取了与可疑电子表格有关的行动的前雇员们，与可疑电子表格有关的行动包括将其植入 SRC 服务器，之后联系 FDA 引导 FDA 检查员找到伪造信息并对 SRC 的程序和研究的可靠性产生怀疑。”

起诉书称，2015 年 6 月 17 日，有人通过用户名和密码访问了 SRC 服务器，并将伪造的数据输入电子表格。“可疑电子表格中包含的信息能证实是不准确的，并且不代表每个相关研究的研究数据。”

SRC 表示，在 FDA 工作人员在现场时以及在为期 10 天的现场检查结束时，公司都有将调查结果呈交给 FDA 检查员。“FDA 检查员拥有所有必要的信息来核实可疑电子表格的内容是否准确和真实，并确定是否其意图真的是证明 SRC 关于这五个研究的研究数据是操纵的的信息的汇编。”

检查后发布的 483 表列出了与数据可靠性和文件保存相关的许多观察项，包括替换研究样品以及未能保护和保存数据文件。

FDA 无视审计结果采取一系列行动

SRC 随后向 FDA 提供了独立审计结果，显示没有数据操纵的证据。然而，2016 年 4 月 19 日，FDA “一概无视”独立审计结果和“SRC 关于可疑电子表格来源的证据和解释，向 SRC 发布了无标题信，称 SRC 在为客户提供服务时未能遵守适用的 FDA 指南和法律。”“FDA 立场的全部基础是可疑电子表格，FDA 关于原告未能解释可疑电子表格的存在并证明可疑电子表格上的信息的立场是无事实根据的。”

尽管 SRC 有 30 天的时间以书面形式通知 FDA 其准备采取的纠正措施，但 FDA 于 4 月 20 日发布通知，声明 SRC 开展的所有研究都是不可接受的 , 并开始向 SRC 的客户发送信息请求。“尽管除了可疑电子表格外没有任何数据操纵的证据，尽管从未有过与 FDA 之前批准的和市场上出售的任何药品有关的负面报告”，FDA 仍采取了这些行动。

作为 FDA 行动的进一步后果，世界卫生组织（WHO）和欧洲药品管理局（EMA）撤销了由 SRC 开展的研究支持的仿制药批准。“EMA 从未执行任何检查 , 仅依赖 FDA 的声明以及 2016 年 4 月 19 日的信函就对原告得出不利结论。根据 WHO、EMA 和 FDA 的结论，马来西亚卫生部等其他国家的药品检测相关的机构以及 SRC 的客户拒绝由 SRC 开展的研究 , 并要求赔偿。”【EMA开始审查基于印度CRO Semler研究的药品 2016/04/29】（本文未在微信发布，请点击文末阅读原文链接，登录识林阅览）

FDA 的不利观察项已经导致其他监管机构对 SRC 开展的所有研究的可信度产生怀疑，从而导致公司声誉和财务状况方面的“巨大损失”。

整理：识林-椒

参考资料

• The Case Of The Suspect Spreadsheet: Semler Sues US FDA Over Data Integrity Concerns - Pink Sheet
  
  

beiwei5du

关于selmer针对于FDA的complaint（起诉书）的部分章节的看法，不管是否存在竞争对手故意栽赃陷害与否，总的上还是显示了selmer本身的数据管理层面存在较多漏洞。
The Semler Complaint Against the FDA


By Barbara W. Unger| March 1st, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspection Stories, FDAzill

Semler Research Center Private Limited (Bangalore, India) is suing the FDA for requiring that sponsors repeat BA/BE studies based on the outcome of an FDA inspection that raised concerns about the trustworthiness and correctness of data.

The legal complaint was filed January 18, 2018, in the US District Court Central District of California. The firm seeks $50,000,000 damages and a jury trial.

• The complaint named eleven (11) individuals, including:
• FDA Commissioner Gottlieb
• Director of Office of Study Integrity and Surveillance
• The Acting Director of the Office of Scientific Investigations within the Office of Compliance
• Director of the Division of Enforcement and Postmarketing Safety
• Acting Branch Chief of Compliance Enforcement Branch of Division of Enforcement and Postmarketing Safety
  

As well as other staff employed at the FDA, including all of the investigators participating in the inspection ending October 9, 2015.

It makes for interesting reading, particularly the section on the 2015-2016 inspection and actions by the FDA that begins on page 10.

It appears that the FDA had a definite idea of what they were seeking when they arrived at the site.  And including two investigators (who have deep experience in GMP electronic records data integrity issues associated with laboratory instruments) seems unusual unless the FDA expected that they would need to review data from these instruments.  We’ll get to this later.

For readers with subscriptions to the Pink Sheet, their January 25th 2018 article on the topic provides additional details.

US Action

The FDA issued a 3-page form 483 to the firm at the close of the inspection on October 9, 2015.  

Observation #1 begins ‘During the inspection, FDA investigators found an Excel spreadsheet on Semler’s server describing the substitution of plasma samples for studies…For example in study [redacted] the spreadsheet indicates that plasma samples from subject 10 who received reference product were substituted by the plasma samples from subject 41 who received test product.’

This form 483 is unusual because all seven observations address, for example:

• Apparent lack of complete data
• Lack of controls over laboratory computer systems so that analysts could delete, copy, and rename chromatographic data
• Failure to retain raw data in the study folder
• Failure to capture audit trails
  

Four investigators from the FDA, including Dipesh Shah and Daniel Roberts, conducted the inspection. These two individuals have been investigators in previous inspections at firms where they identified serious data integrity breaches.

The firm received an untitled letter in April 2016 based on the observations identified in this inspection.

The FDA inspected the same site on September 15th 2014 and December 13th 2013, and did not issue a form 483 for either inspection. One of the investigators at the 2014 and 2015 inspection was the same, Arindam Dasgupta.

[RELATED: Want to read and analyze the 483s mentioned here? Check out FDAzilla’s Enforcement Analytics to have immediate and unlimited access to the world’s largest FDA enforcement action database.]

EMA Action

As if US action was not enough, the EMA recommended suspension of medicines evaluated at the site based on the FDA and WHO inspections.

WHO conducted inspections at the site in January 2015 with follow up inspections in December 2015 and published a notice of concern on April 12th 2016 regarding their findings.

In conclusion, they state “The above problems observed at Semler and other problems described in the report, indicate the existence of a general or systematic deviation from commonly accepted quality standards, and cannot be ascribed to a single person or two working outside of the quality management system. On these grounds, the PQT [Pre-qualification team] recommends an immediate stop for all submissions of dossiers relying or in whole or in part on involvement from Semler until the underlying issues have been verified to have been adequately resolved.”

It seems most unusual that the inspections in 2013 and 2014 did not result in the issuance of a form 483. But, then in 2015, a reasonably short form 483 identified serious problems in the area of data management and resulted in serious consequences for the firm.

Though I have no data for this supposition, it seems to suggest the involvement of a whistlebloweror the FDA gaining some information to convince them that a potentially serious problem existed at the site along with information identifying the nature of the problem and where to look for evidence of these problems. Details for this supposition are addressed in the following section.

Let’s start with the information provided on page 10 of the Semler complaint and look at some of the elements that make the conduct of this inspection unusual.

• Paragraph 31 says that investigators arrived at 7:30 AM before normal operating hours.  In my experience, the FDA respects a firm’s operating hours.  
  
  • Also, in Paragraph 31, the complaint states that the FDA ‘insisted upon accessing the BA/BE laboratory without waiting for the responsible staff members of SRC to arrive.’
    
    • Again, in my experience, the FDA awaits escorts from the firm before entering non-administrative areas of the facility.  This approach suggests to me that the FDA was concerned about the possible destruction of records before they could begin the inspection.
      
  • Also, a ‘clue’ that something unusual was afoot, Paragraph 32 in the claim states that ‘FDA Inspectors informed SRC that this was not a project-specific inspection but rather was an inspection to verify the computer validation and related aspects of BA/BE testing’ and that ‘FDA…told SRC’s staff not to retrieve any documents until they made a request for the same.’ The FDA’s previous inspections of the facility were reported to be product specific.
    
    • Again, the request for the firm not to retrieve any documents until the FDA requested them suggests a concern about possible record destruction.
      
    
    
  
  

• Paragraph 41 gives a clue of the FDA’s focus where the complaint states ‘Multiple times FDA Inspectors went to the BA/BE instrument room and checked the Instrument Computer system connected to the instrument and compared that with the access given in the conference room.’
  
  • Investigators appear to be searching for a specific document.  
    
  
  

• Paragraph 43 describes that an SRC employee saw one investigator looking at a picture they had taken that showed a ‘File Explorer window open to a server identified by the letter “Y” and showing a document path to a particular folder’ to which FDA investigators did not yet have access.  The complaint states that the folder in question was titled ‘DUMP.’ After more back and forth to the laboratory where a search revealed ‘the contents of one part of that file’ after which the investigator asked that the firm print out the file.
  

• Paragraph 45 identifies the file as ‘…a Microsoft Excel spreadsheet file titled “March 2010 version 1xls.xls…”‘ Paragraph 46 of the complaint indicated that ‘FDA Inspectors, having seemingly found what they were looking for from the start…’
  

• In Paragraph 47 of the complaint, Semler Research Corporation maintains that a rogue employee intentionally falsified data in the problematic spreadsheet referenced in the first observation of the inspection form-483. SRC believes that this act was the result of a collaboration between this ‘rogue employee’ acting with others at a neighboring firm who were perceived to be a competitor of SRC.
  

• Paragraph 57 of the claim states that that ‘on June 17, 2015, someone accessing the SRC Server system…fabricated data into the Suspect Spreadsheet.’  Most of the staff were reported to have been at lunch during this time.
  

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Regardless of whether or not this was an intentional act meant to harm a competitor, SRC appears to have deficiencies in how they manage both paper and electronic data to ensure records supporting the conduct of BA/BE studies are trustworthy and complete. For example:

• Observation 5 identifies ‘bioanalytical data worksheets were discovered crumpled/torn in a trash pile on the floor or otherwise discarded inside the bioanalytical laboratory.’
• The firm failed to have the data necessary to reconstruct the study which is also a serious concern.
• Three LCMS instruments did not have enabled audit trails. Thus, key data on who performed specific operations and when they performed them cannot be determined.  It is also not possible to determine if data was modified or deleted.
• Analysts had privileges in the LCMS instrument systems that allowed them to ‘delete, copy and rename chromatographic LC/MS raw data….’
• And, finally, it appears that the firm did not develop and maintain spreadsheets in an environment where additions, deletions, or changes could be captured in an audit trail.
  

Regardless of whether the addition of data to the spreadsheet was nefarious with the intent to do business harm, it does seem to indicate that SCR did not have sufficient security controls over their electronic systems. If the firm maintained the spreadsheet in a controlled environment, it should have been possible to determine who made the problematic additions to the spreadsheet in question.

We will continue to watch this case. It would be enlightening to see if the FDA EIR for the inspection reflects the same ‘story’ as the legal complaint.

SRC is not the first firm to sue the FDA.  Apotex, a Canadian generic drug manufacturer, sued the FDA in 2012. They claimed to suffer harm when the FDA imposed an Import Alert based on the outcome of an inspection of their Etobicoke, Canada site ending on December 19, 2008.  In 2012, they again sued the FDA in the US District Court for the District of Columbia for what they felt were unreasonable delays in re-inspection of a manufacturing site.

It’s also not the first time that a BA/BE firm in India has been the recipient of EMA enforcement actions. In 2015, the EMA recommended that multiple medicines be suspended based on clinical studies at GVK.  

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

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About the Author

Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.

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