US FDA issues Lupin Form 483 for manufacturing practices violation
US FDA observed that Lupin failed to review and investigate discrepancy in a drug production batch at the Goa plant
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Mumbai: The US Food and Drug Administration (FDA) has issued a form 483 to Lupin Ltd’s Goa facility, citing three observations related to violation of good manufacturing practices following an inspection of the site between 27 March and 7 April this year.
Shares of the company fell to a 52-week low of Rs1,334 on the BSE on Thursday. The stock ended down 2.5% at Rs1,337.25, while the benchmark Sensex closed 0.3% lower at 30029.74 points.
The US drug regulator observed that the company failed to review and investigate unexplained discrepancy and out of specification components of a product batch at the facility, according to the form 483, available on the FDA website.
“From January 2016 to March 2017, your firm has invalidated several initial out of specification (product) results…You invalidated the initial results without adequate investigation, performed re-testing using new samples and reported the average results of replicate re-tests,” the FDA said in the form 483.
The FDA issues a form 483 if its investigators spot any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
The regulator also observed that Lupin did not have written procedures for production and process controls to assure quality of the product is as it is supposed to be as well as any established control procedures to monitor output of those manufacturing processes that cause variability in the characteristics of the drug.
An email query sent to Lupin did not elicit any response.
“These observations do not look very serious in nature and Lupin should be able to resolve them within one or two quarters,” Amey Chalke, research analyst, pharma, HDFC Securities said.
The Goa facility is an important unit for the company as its accounts for 30-40% of US sales. In the quarter ending in December 2016, Lupin’s US sales grew 53.4% to $316 million.