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Caplin's sterile injectable site in Chennai gets two USFDA observations

Caplin Point Laboratories said it believes these observations are procedural in nature and corrective

Press Trust of India  |  New Delhi 

Drugs, Pharma, medicine

Point Laboratories Monday said the US health regulator has made two observations after completion of inspection at its subsidiary's sterile injectable site in Tamil Nadu.

The (USFDA) has completed inspection of Steriles Ltd'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, Point Laboratories said in a BSE filing.

said it believes these observations are procedural in nature and corrective and "preventive actions for these observations will be presented to the shortly".

"The observations made were not repeat observations or related to data integrity. This was the third audit at the plant since 2016," the company added.

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 were trading 0.64 per cent lower at Rs 420 apiece on BSE.

First Published: Mon, June 17 2019. 12:35 IST
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