Sun Pharmaceutical Industries Ltd announced that it has received a Warning Letter from the US FDA as a result of the September 2014 inspection, for its facility located at Halol, Gujarat in India.
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.
Since the inspection in September 2014, Sun Pharma 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.
Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations
to its customers and the patients who use its drugs in the United States and around the world.
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.
Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations
to its customers and the patients who use its drugs in the United States and around the world.
Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated time frame.
