Piramal Pharma has recently informed exchanges that the US Food and Drug Administration recently carried out a general Good Manufacturing Practices (GMP) inspection at the company’s Lexington facility in Kentucky, USA. The audit took place between 3 December and 10 December 2025 and concluded with the issuance of a Form 483 containing four observations.
According to the company, the points raised by the regulator relate mainly to procedural enhancements and are expected to be classified as VAI, or Voluntary Action Indicated. This classification generally suggests that the FDA has not identified critical or systemic issues but expects the company to improve certain processes. Piramal Pharma has already begun preparing a detailed response and plans to submit it to the FDA within the required timelines.
The management noted that Piramal Pharma remains fully committed to meeting the highest quality and compliance standards across all its facilities. The company also emphasised that it will work closely with the agency to address each observation comprehensively and ensure continued adherence to global regulatory expectations.
