USFDA issues Form-483 with 3 observations to Alkem Lab’s St Louis plant

Alkem Laboratories on Thursday said the US health regulator has issued three observations after inspecting its St Louis-based manufacturing facility. The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection at the plant from October 31, 2022 to November 9, 2022, the drug firm said in a regulatory filing.

At the end of the inspection, the company received Form 483 with three observations, it added.

“There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations,” the company said.

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

(With inputs from health)