Natco Pharma concluded a US FDA inspection at its Manali, Chennai API facility, resulting in seven Form 483 observations. The company described the findings as procedural, not related to product quality, and said it will submit a comprehensive response. The inspection ran from November 17–21, 2025.
Natco Pharma Limited announced the completion of a US FDA inspection at its Active Pharmaceutical Ingredients (API) manufacturing unit in Manali, Chennai. The review covered quality systems, processes, and compliance, culminating in seven Form 483 observations issued by the agency.
Management emphasized that the observations are procedural in nature and do not pertain to product quality. Natco stated confidence in addressing all points through a detailed remediation plan and reaffirmed its commitment to cGMP compliance and maintaining high standards across its global supply chain.
The outcome signals a regulatory follow-up phase, during which Natco will respond to the FDA with corrective and preventive actions (CAPA). Such findings are common in routine inspections and typically lead to process enhancements rather than supply disruptions when addressed promptly and effectively.
Notable updates
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Inspection window: November 17–21, 2025, at Manali, Chennai API unit
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Observations issued: Seven on Form 483
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Nature of findings: Procedural; not linked to product quality
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Next steps: Comprehensive response and CAPA to FDA
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Commitment: Continued adherence to cGMP and quality systems
Sources: Business Upturn, InvestyWiseInvestyWise, ScanX News