Update on Dr. Reddy
In fresh trouble for Dr. Reddy's Laboratories (DRL), a warning letter has been uploaded on the US Food and Drug Administration website with regards to DRL's plants it had inspected recently. The administrator has identified significant deviations from current good manufacturing practices (CGMP) at three of DRL's plants.
The three plants that were inspected earlier by US FDA were Unit VI of Srikakulam Plant, Unit V at Telangana's Miryalaguda Taluk Plant and Unit VII at the Duvvada Plant in Visakhapatnam.
The American regulator says it has identified significant deviations from CGMP at all three plants. For the plant units in Srikakulam and Miryalaguda the deviations lay for manufacturing active pharma ingredients (API's), while for the Oncology Plant at Duvvada, the problem lay with finished pharmaceutical products.
Further, the regulating authority has said that the firm's responses from December 15th, 2014 to March 27th, 2015 lack sufficient corrective actions.
The US FDA's take on Srikakulam Plant is that presence of an uncontrolled ‘Custom QC Lab" was discovered by inspection team and existence of this lab was unknown previously to the regulator. This CQC lab was intended for export to US through 2012. Discovery was made one day before the end of the inspection, the regulator reported.
On the Miryalguda Taluk Plant, the body has said that DRL's response on US FDA investigations was inadequate while for the issues at the Duvaada Plant, the company failed to thoroughly investigate any unexplained discrepancy or failure of batch of its components to meet any of the specifications.
The deficiencies found has led the US regulator to question effectiveness of current corporate quality system to achieve overall compliance with CGMP. Further, it said several violations have been recurrent or represent long-standing failures. It is apparent that the company has not implemented a robust quality system at the sites, US FDA adds.
The three plants that were inspected earlier by US FDA were Unit VI of Srikakulam Plant, Unit V at Telangana's Miryalaguda Taluk Plant and Unit VII at the Duvvada Plant in Visakhapatnam.
The American regulator says it has identified significant deviations from CGMP at all three plants. For the plant units in Srikakulam and Miryalaguda the deviations lay for manufacturing active pharma ingredients (API's), while for the Oncology Plant at Duvvada, the problem lay with finished pharmaceutical products.
Further, the regulating authority has said that the firm's responses from December 15th, 2014 to March 27th, 2015 lack sufficient corrective actions.
The US FDA's take on Srikakulam Plant is that presence of an uncontrolled ‘Custom QC Lab" was discovered by inspection team and existence of this lab was unknown previously to the regulator. This CQC lab was intended for export to US through 2012. Discovery was made one day before the end of the inspection, the regulator reported.
On the Miryalguda Taluk Plant, the body has said that DRL's response on US FDA investigations was inadequate while for the issues at the Duvaada Plant, the company failed to thoroughly investigate any unexplained discrepancy or failure of batch of its components to meet any of the specifications.
The deficiencies found has led the US regulator to question effectiveness of current corporate quality system to achieve overall compliance with CGMP. Further, it said several violations have been recurrent or represent long-standing failures. It is apparent that the company has not implemented a robust quality system at the sites, US FDA adds.
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