Dr Reddy’s 准备再次申请re-inspection

beiwei5du

两处工厂。
一个是Duvvada Visakhapatnam facility制剂工厂，自从2015年被发了警告信后，2017年3月的重新检查又被发了13条的483 observations，现在准备在六周内再次进行申请re-inspection.
另一个是位于Srikakulam的API工厂，自从2015年被发了警告信后，其后有申请过两次re-inspection，都没有过并均被发了483表，第一次是483（2017.04），第二次发的483（2017.06），最后一次的observations相对比较简单，仅有一个observation，其暂时不清楚是否需要进行申请re-inpection。

Dr Reddy’s prepares for Duvvada re-inspection following Form 483
By Flora Southey
24-May-2018 - Last updated on 24-May-2018 at 14:14 GMT

Getty/Jirsak

Dr Reddy’s expects to have addressed all GMP violations at its Duvvada drug formulation plant and Srikakulam API facility within the next six weeks, says CEO.
The Indian drugmaker has attracted regulatory attention from the US Food and Drug Administration (FDA) over the past few years for its Duvvada and Srikakulam facilities.
The agency issued Dr Reddy’s Duvvada facility – which formulates cancer drugs – a Form 483 with 13 observations in March last year.
The company also received an FDA warning letter for the site in 2015.
Earlier this week, CEO GV Prasad told investors the firm has done a “lot of work on remediation over the last 12 months” at its Duvvada facility in Vishakapatnam, India.
“We expect to go back to the FDA end of June and request a re-inspection,” he added, highlighting that the re-inspection may not be conducted immediately.
Srikakulam API plant update
Dr. Reddy’s is also addressing good manufacturing practice (GMP) issues at its Srikakulam active pharmaceutical ingredient (API) plant.
In November 2014, the facility – located in India’s southeastern state of Andhra Pradesh – received an FDA Form 483 with nine observations about the plant’s procedures.
In November 2015, the site received a warning letter from the US regulator.
“We are not yet clear whether [the Srikakulam facility] will require a re-inspection because the inspection that happened was fairly straight-forward,” said Prasad.
The company expects to have addressed all concerns within the next six weeks, he told investors.
“After that, we will have to ask the FDA what the next step should be,” he added.

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