New Delhi, February 10 Drug maker Cipla said that the US health regulator has issued Form 483 with two observations after inspecting a manufacturing facility of its US-based unit, InvaGen Pharmaceuticals, Inc.
A Pre-Approval Inspection was conducted by the US Food and Drug Administration (USFDA) at the manufacturing facility of InvaGen from February 2 to February 9, 2023, the Mumbai-based drug maker said in a regulatory filing.
"Following the inspection, InvaGen has received two observations in Form 483. The company will work closely with the USFDA and is committed to addressing these comprehensively within the stipulated time," it added.
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.