The US Food and Drug Administration (USFDA) has issued a warning letter to Lupin for violation of current good manufacturing practice norms at two of its manufacturing facilities in Goa and Indore. "Your firm frequently invalidated initial out-of- specification (OOS) laboratory results without an adequate investigation that addressed potential manufacturing causes," USFDA said. Besides, the Mumbai-based drug firm failed to establish appropriate time limits for the completion of each phase of production to assure the quality of the drug product, it added. On Lupin's Pithampur (Indore) plant, the US health regulator said the company invalidated initial OOS laboratory results without adequate investigations. "Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to assist your firm in meeting CGMP requirements," USFDA said.

Source: Economic Times November 16, 2017 12:11 UTC