Sun Pharma receives warning letter for Halol plant

19 Dec 2015 Evaluate

Sun Pharmaceutical Industries has received a warning letter from the United States Food and Drug Administration (USFDA) over violation of manufacturing norms in its facility at Halol in Gujarat. The warning letter follows inspection of the facility in September 2014 by USFDA inspectors. The company has 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. The company has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner.

Since the inspection in September 2014, the company 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. The company expects to request a re-inspection by US FDA upon completion of its remediation commitments.

The company 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 US and around the world. The company will respond to this Warning Letter with a detailed plan within the stipulated time frame.


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