Lupin could face FDA regulatory action over Tarapur API facility13 Jan 2020
India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.
“The company has received a communication from the US FDA classifying the inspection conducted at its Tarapur manufacturing (API) facility between September 16 to September 20, 2019 as Official Action Indicated,” Lupin said in a filing to the Bombay Stock Exchange.
According to the FDA’s official definition, an OIA means that “objectional conditions were found and regulatory administrative sanctions by FDA are indicated.”
Lupin said in the filing it did not believe that the inspection classification would have an impact on disruption of supplies or the existing revenues from operations of the facility.
“The company is in the process of sending further updates of its corrective actions to the US FDA and is hopeful of a positive outcome,” Lupin said.
Back in October, the FDA issued a Form 483 listing three observations of violations of current good manufacturing practices (cGMP) at the Tarapur plant.
In the letter, the FDA said Lupin had failed to maintain batch production and control records and not carried out a satisfactory review of unexplained discrepancies “whether or not the batch has already been distributed.”
The FDA also cited failure by workers at the plant “to handle and store cleaned utensils in a manner to prevent contamination.”
Separately in another exchange filing on January 11, Lupin said the FDA had completed a Prior Approval Inspection at its Nagpur oral solid dosage manufacturing facility between January 6 and January 10, closing with 483 observations.
Lupin managing director, Nilesh Gupta said the company was committed to meeting the highest quality standards and to full compliance with current good manufacturing practice regulations at all its manufacturing facilities.
“We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline,” he added.
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