Drug Approval | January 12, 2023
USFDA inspects Piramal Pharma Lexington facility
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
With the receipt of the EIR, the inspection stands successfully closed.
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
FDA changes inspection classification of the facility to Voluntary Action Indicated
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