Lupin informed that US FDA inspected its Nagpur Unit-2 injectable manufacturing facility from October 17, 2022, to October 29, 2022.

The injection facility was subjected to a Pre-Approval Inspection. The inspection concluded with the issuance of a Form-483 containing five observations.

The company stated that it is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing in the US.

According to the US Food and Drug Administration (USFDA), Form 483 is issued to a company's management at the end of an inspection if the investigator notices any conditions that may indicate violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.