USFDA pulls up Smruthi Organics for norms violation in unit

PTI New Delhi | Updated on October 21, 2013 Published on October 21, 2013

Smruthi Organics today said it has received a notification from the USFDA highlighting violations of manufacturing norms at its Solapur plant, in yet another instance of an Indian drug maker failing to comply with norms of the US health regulator.

In a filing to the BSE, the company said the European Directorate for Quality of Medicines (EDQM) and the US Food and Drug Administration (USFDA) have inspected its active pharmaceutical ingredients site from October 14-18, 2013.

“USFDA has issued their observations in form 483. EDQM is yet to submit its final inspections report,” Smruthi Organics Ltd added.

It, however, did not specify the shortcomings found by the USFDA inspectors at its plant.

“After the resolution of the observations to the satisfaction of the regulators, the company will be able to resume supplies of its products to the EU and US markets,” Smruthi Organics said.

A USFDA Form 483 is issued to a firm after completion of an inspection when its investigator(s) observe any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, notifying the objectionable conditions.

India’s drug majors Ranbaxy Laboratories and Wockhardt have been in the news after their different plants were found to be violating the current good manufacturing norms of the USFDA.

Ranbaxy has agreed to pay a $500-million penalty to US authorities after its plants at Paonta Sahib and Dewas were found to be violating norms. USFDA has also recently banned import of drugs made at its Mohali plant.

Wockhardt is also trying to resolve issues after its plants at Waluj and Chikalthana were found not adhering to norms specified by the USFDA.

Published on October 21, 2013
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