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USFDA issues warning letter to Lupin's Goa, Indore plants

USFDA issued a warning letter to Lupin for violation of current good manufacturing practice norms at two of its manufacturing facilities in Goa and Indore

Press Trust of India  |  New Delhi 

medicine, pharma, drugs

The US Food and Drug Administration (USFDA) has issued a warning letter to for violation of current good manufacturing practice norms at two of its manufacturing facilities in and

In a letter to Managing Director Nilesh Gupta, 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 plant, 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," 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," 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 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 and Pithampur plants into the United States, it added.

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First Published: Thu, November 16 2017. 19:39 IST
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