USFDA Flags Four Observations at Piramal Pharma’s Lexington Site
Piramal Pharma Receives USFDA Observations Piramal Pharma’s Lexington, Kentucky facility underwent a USFDA GMP inspection from 3–10 December 2025. The regulator issued a Form 483 with four observations
Observations Expected to Be VAI The four USFDA observations relate to procedural enhancements and are expected to fall under the Voluntary Action Indicated category. The company is preparing a detailed response
Company Ensures Compliance Commitment: Piramal Pharma stated it remains committed to the highest quality standards and will work closely with the regulator to address all concerns raised during the inspection
About Piramal Pharma’s Global Operations PPL operates 17 global facilities and serves over 100 countries. Its businesses include Piramal Pharma Solutions, Piramal Critical Care, and India Consumer Healthcare
Financial Performance Snapshot The company reported a consolidated net loss of ₹99.22 crore in Q2 FY26 versus a profit of ₹22.59 crore last year. Revenue dropped 8.83% YoY to ₹2,043.72 crore