The company expects a re-inspection by US FDA
Sun Pharmaceutical Industries has received a warning letter from the US FDA as a result of the September 2014 inspection, for its facility located at Halol, Gujarat.
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.
Dilip Shanghvi, Managing Director, Sun Pharma said, “While our 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.”
Post the 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.