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US FDA Flags Seven Observations at Natco Pharma’s Chennai Manufacturing Plant
- By Newsdesk
- New Delhi
- Nov 23, 2025
Natco Pharma Limited has announced that the U.S. Food and Drug Administration (FDA) issued seven observations for its active pharmaceutical ingredients (API) facility in Manali, Chennai, following an inspection carried out between 17 and 21 November.
The inspection concluded with a Form-483, a document issued when FDA investigators identify conditions that may be in violation of U.S. regulatory standards. In its exchange filing, the company described the observations as “procedural in nature” and said it is taking immediate steps to address each point raised.
Natco Pharma assured that it remains committed to operating in full compliance with current good manufacturing practices (cGMP) and to maintaining the quality and safety of its products supplied worldwide. The company added that it is actively engaging with regulators and expects to bring the facility into complete alignment with FDA expectations.
The notice comes at a time when global regulatory bodies continue to intensify oversight of pharmaceutical manufacturing sites, particularly those serving U.S. and other major export markets. All eyes will be on Natco’s remediation progress as it works to close out the observations.