The US Food and Drug Administration (FDA) has issued a Warning Letter to Sun Pharmaceutical Industries Ltd. as a result of a September 2014 inspection, for the company’s facility located at Halol, Gujarat in India. The Halol facility manufactures injectable products for the US market. 

Sun confirmed receipt of the Warning Letter in a December 19, 2015, statement and said that the company “has responded to the US FDA inspection observations with a robust remediation process that is still ongoing, 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.”

Commenting on the development, 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.

Since the inspection in September 2014, Sun Pharma said it has communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. It has provided periodic updates to the US FDA on its commitments. 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.

Source: Sun Pharma