Piramal Pharma Gets FDA Form 483 After Lexington Site Inspection

Piramal Pharma drew attention today as the US FDA wrapped up a general Good Manufacturing Practices inspection at the company’s Lexington, Kentucky site.

The review, held from December 3 to December 10, 2025, ended with a Form 483 containing four observations. These points focus on procedural improvements and are expected to fall under the Voluntary Action Indicated (VAI) category, a sign that the regulator sees the issues as correctable without major enforcement.

The company said it is preparing a detailed response within the required timeline and stressed that it remains committed to strong compliance standards. Piramal Pharma noted it will continue working with the regulator to address every point raised during the inspection.

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As a global healthcare player, Piramal Pharma operates 17 manufacturing sites and distributes products across more than 100 countries. Its business includes Piramal Pharma Solutions, a full-scale Contract Development and Manufacturing Organization; Piramal Critical Care, which focuses on complex hospital generics; and the India Consumer Healthcare division, known for its over-the-counter brands.

Financial performance, however, has been under pressure. The company posted a consolidated net loss of Rs 99.22 crore in Q2 FY26, a sharp turn from the Rs 22.59 crore profit reported in the same quarter last year. Revenue declined 8.83% YoY to Rs 2,043.72 crore, reflecting softer demand across key segments.

Despite the challenging quarter and the FDA’s latest feedback, Piramal Pharma emphasized that it remains focused on operational discipline and quality systems as it works to stabilize performance and maintain trust within the global pharmaceutical industry.