Sun Pharma's Halol plant receives US FDA's warning letter

In a major setback, Sun Pharmaceutical has received a warning letter from the US Food and Drugs Administration (FDA) for its facility located at Halol, Gujarat, following an inspection conducted by the US drug regulator in September 2014.
 
Sun Pharma responded to the US FDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its quality systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner, said the company in a statement.
 
Commenting on the development, Dilip Shanghvi, managing director, Sun Pharma, said, “Whileour team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility. Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market. We are pledged to being current good manufacturing practices (cGMP) compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications."
   
Post September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved. Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments.