Cipla Gets USFDA Form 483 for US Plant

New Delhi, Feb 10 (PTI) Drug maker Cipla said 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, 2026, the Mumbai-based drug maker said in a regulatory filing.


"On conclusion of the inspection, InvaGen has received two inspectional observations in Form 483. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time," it added.

As per 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.