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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.
In a letter to Lupin Managing Director Nilesh Gupta, USFDA said inspectors during an inspection from March 27 to April 7, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," it noted.
Elaborating on the violations at the Goa plant, USFDA said the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
"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.
The company should immediately and comprehensively assess its global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all sites, it added.
Until the company corrects all violations and deviations completely and the USFDA confirms its compliance with CGMP, it may withhold approval of any new applications, it said.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Lupin's Goa and Pithampur plants into the United States, it added.
Lupin shares today ended 0.81 per cent up at Rs 829.30 apiece on the BSE.