Lupin Tarapur facility cautioned by USFDA post inspection
"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 (OAI)," Lupin said in a filing to BSE.
New Delhi: Drugmaker Lupin Ltd on Monday said the US health regulator has cautioned that its Tarapur manufacturing facility may be subject to regulatory actions.
"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 (OAI)," Lupin said in a filing to BSE.
Also Read: Lupin Tarapur API facility gets 3 observations from USFDA
According to USFDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by USFDA are indicated" during inspections.
The inspection at the Tarapur facility had closed with three observations.
Also Read: Lupin gets 2 observations from USFDA for Nagpur facility
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