The warning letter follows inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors.

The firm and the Halol facility will continue to supply important drug products to meet its obligations towards the customers and the patients who use its drugs in the US and around the world, it added.

Commenting on the development, Sun Pharma Managing Director Dilip Shanghvi said, "While our team is working hard to ensure that the commitments made to the USFDA in September 2014 are fully completed, we will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility."

Sun Pharma said it had responded to the USFDA inspection observations with a "robust remediation process that is still ongoing, 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, it added.

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