USFDA issues Form 483 with 7 observations to Natco's Chennai API unit

New Delhi, Nov 21 (PTI) Natco Pharma on Friday said the US health regulator has issued seven observations following an inspection of its Chennai-based API unit.

The US Food and Drug Administration (FDA) conducted an inspection at the API manufacturing plant located in Manali, Chennai, India, from November 17-21, 2025, the drug maker said in a regulatory filing.

The company received seven observations post-inspection in the Form-483, it added.

The drugmaker believes the observations are procedural in nature, Natco Pharma said.

The company is confident that it can address these observations comprehensively, it added.

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