The U.S. FDA has issued a warning letter after conducting a review of Sun Pharma's initial response to the issues raised during a November 2013 inspection of a now-banned facility, and found that Sun Pharma has failed to take adequate corrective actions.
Sun's plant in question - in Karkhadi, Gujarat, India - has been banned from importing to the U.S. since March.
The FDA cited examples from the inspection that suggest a general lack of reliability and accuracy of data generated by Sun Pharma's laboratory, including the drugmaker's practice of “unofficial testing” of samples and disregarding of the results.
The FDA investigation found 47 instances of apparent "trial injections" of samples with out-of–specification results. Some of these batches were then distributed to the U.S. market.
According to the FDA, until all corrections have been completed and confirmed by the FDA , the agency may withhold approval of any new applications and continue to refuse admission of articles manufactured at the Karkhadi plant.
Read the FDA Warning letter