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Sandoz, a Novartis company and a world leader in generic pharmaceuticals, has received a warning letter from the US health regulator USFDA. This warning letter was issued for violations of current good manufacturing practice (cGMP) norms at its two plants in West India.
“On October 22, 2015, the US Food and Drug Administration (USFDA) issued a warning letter to our Sandoz Division concerning their Indian sites in Kalwe and Turbhe, Maharastra,” Novartis AG said in its quarterly result statement.
The warning letter observations follow USFDA inspection at both sites in August 2014 and are related to deficiencies in current good manufacturing practice (cGMP) for finished pharmaceuticals, it added.“The warning letter does not contain any new issues versus the 483 observations issued following the inspection in August 2014, which Sandoz has been addressing since then,” the company said.
Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency’s full satisfaction, it added. No supply disruptions are expected, the company noted. At Turbhe, Sandoz mainly produces active pharmaceutical ingredients at Turbe and oral solid dosages or tablets are produced in Kalwe.