MUMBAI -- The U.S. Food and Drug Administration has issued a warning letter to Sun Pharmaceutical Industries Ltd about its Halol facility after an inspection revealed problems with its manufacturing processes, the firm said on Saturday.
The U.S. drug watchdog has withheld product approvals from the unit in western India since the inspection in September 2014.
Sun Pharma said in a statement that it was taking steps to address the problems outlined by the FDA and that it would request a re-inspection of the Halol facility once it had completed the remedial steps.
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The U.S. drug watchdog has withheld product approvals from the unit in western India since the inspection in September 2014.
Sun Pharma said in a statement that it was taking steps to address the problems outlined by the FDA and that it would request a re-inspection of the Halol facility once it had completed the remedial steps.
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