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US FDA makes 2 observations for Caplin’s sterile injectable site in Chennai

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Caplin Point Laboratories said it believes these observations are procedural in nature and corrective and “preventive actions for these observations will be presented to the US FDA shortly”

Caplin Point Laboratories has announced that the US health regulator has made two observations after completion of inspection at it is subsidiary’s sterile injectable site in Tamil Nadu. The US Food and Drug Administration (US FDA) has completed inspection of Caplin Steriles’s site at Gummidipoondi in Tamil Nadu, between June 6-14, 2019.

At the end of this scheduled Good Manufacturing Practice (GMP) inspection, there were only two observations, Caplin Point Laboratories said in a BSE filing.

Caplin Point Laboratories said it believes these observations are procedural in nature and corrective and “preventive actions for these observations will be presented to the US FDA shortly”. “The observations made were not repeat-observations or related to data integrity. This was the third US FDA audit at the plant since 2016,” the company added.

Caplin Point Laboratories Chairman C C Paarthipan said: “our primary focus is to ensure integrity and maintain transparency in our quality systems, and we’re pleased with the result of yet another successful audit.”

Shares of Caplin Point Laboratories were trading 0.64 per cent lower at Rs 420 apiece on BSE.

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