USFDA flags 3 manufacturing compliance lapses at Lupin's New Jersey unit

Pharma major Lupin Ltd on Saturday said the US health regulator has issued Form 483 with three observations to its Somerset, New Jersey, facility in the US following an inspection.

The USFDA has concluded the inspection at our manufacturing facility located in Somerset, New Jersey, USA, Lupin said in a regulatory filing.

"The inspection was conducted from April 13, 2026, to April 17, 2026, and closed with the issuance of a Form-483 with three observations," it added.

The company further said, "We will address the observations and respond to the USFDA within the stipulated timeframe".

Lupin said it is "committed to be compliant with CGMP standards across all our facilities".

 

According to the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.