Ipca Laboratories announces the conclusion of a US FDA inspection at its Active Pharmaceutical Ingredients (APIs) manufacturing facility in Tarapur (Palghar-Maharashtra). The inspection, conducted from December 1, 2025, to December 5, 2025, resulted in the issuance of a Form 483 with 3 observations. The company plans to respond comprehensively to address the FDA’s concerns.
US FDA Inspection Update
Ipca Laboratories has completed a US FDA inspection of its Active Pharmaceutical Ingredients (APIs) manufacturing facility located in Tarapur, Palghar-Maharashtra. The inspection took place between December 1, 2025, and December 5, 2025.
Key Findings and Next Steps
At the conclusion of the inspection, the US FDA issued a Form 483, noting 3 observations. Ipca Laboratories has committed to providing a comprehensive response to the FDA regarding these observations. The company aims to address the concerns raised within the stipulated timeframe and will work closely with the agency to resolve these issues promptly. The company emphasizes its commitment to maintaining high standards of quality and compliance at all its manufacturing facilities.
Source: BSE