Smruthi Organics faces USFDA heat for GMP issues
Recently many Indian drug companies have been under USFDA scanner, especially for the Good manufacturing practice (GMP) concerns. After many large drug players, now it seems to be the turn of Smruthi Organics to face violation of GMP norms. According to the company’s statement, the USFDA has issued a notification, which elaborates the manufacturing practice (GMP) violations at its manufacturing unit at Solapur in Maharashtra. .The USFDA has issued a Form 483, after an USFDA inspection of the given manufacturing site and the observed violations of Food, Drug and Cosmetics Act are notified in the form of observations. The Solapur manufacturing site has been inspected by USFDA as well as EDQM (European Directorate for Quality of Medicines). The company has not received the final inspection report from EDQM.
After the company resolves the identified GMP issues and provides satisfactory resolution of the observations, the company will be allowed to resume manufacturing and supplying of their products to the Us and European markets.