Lupin has informed that the US FDA inspected Lupin’s Somerset, New Jersey, USA manufacturing facility from January 2, 2023 to January 13, 2023. 

According to the filing, the inspection closed with the issuance of a Form-483 with two observations. 

'We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," the company said in a statement.

It further added, "We uphold quality and compliance with utmost importance and are committed to being compliant with CGMP standards across all our facilities."