Piramal Pharma Limited’s facility at Turbhe in India has received a Form-483 from the US FDA after a recent General GMP (Good Manufacturing Practice) inspection. The inspection, which took place from February 11th to February 17th, 2025, resulted in 6 observations. While the observations are related to improving procedures and practices, they are not related to data integrity.
A Form-483 is a notification from the FDA to the facility owner, outlining the agency’s observations and requiring a response. The company is preparing a detailed response to the observations, which will be submitted to the agency within the stipulated time frame.
It’s worth noting that the observations are focused on procedural and practice improvements, which suggests that the facility is not in non-compliance with cGMP regulations regarding data integrity. This is a significant development, as it implies that the facility is not at risk of being shut down or having its exports restricted. Instead, the company is required to address the procedure-related issues to ensure compliance and maintain compliance.
The outcome is a positive sign for Piramal Pharma, as it demonstrates the facility’s compliance with cGMP regulations and its commitment to maintaining good manufacturing practices. The company’s prompt response to the observations will likely help to address any concerns and prevent any potential issues in the future. Overall, the brief is a testament to the facility’s commitment to quality and its ability to adapt to regulatory requirements.