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.CCI Newswire
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