Now, Smruthi Organics under FDA lens for norms violation
Yet another Indian pharma firm has come under the scanner of the US Food and Drug Administration (FDA) with the health regulator pulling up Smruthi Organics for violation of norms.
It may be recalled that recently, several firms including Ranbaxy Laboratories, Aurobindo Pharma, Dr Reddy’s Laboratories and Wockhardt were under the FDA lens for alleged violation of Current Good Manufacturing Practices (CGMP) at their respective production units both in India and overseas.
According to Smruthi Organics, it has received a notification from the US FDA pointing out violations of manufacturing practices at its Solapur plant.
“US FDA has issued their observations in form 483. EDQM (European Directorate for Quality of Medicines) is yet to submit its final inspections report,” Smruthi Organics said on Monday.
Form 483 is issued to a firm after completion of an inspection when its investigator observe any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, notifying the objectionable conditions.
It added that both the US FDA and EDQM have inspected its facility, which produces active pharmaceutical ingredients between October 14 and 18, 2013.
“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.”
Meanwhile, Ranbaxy agreed to pay $500 million penalty to the US authorities after its plants at Paonta Sahib and Dewas were found to be violating norms. The FDA banned import of drugs from Ranbaxy’s Mohali plant. Similarly, Wockhardt is also trying to resolve issues after its Waluj and Chikalthana units were found violating norms.