Indian pharmaceutical manufacturer Sun Pharmaceutical Industries Ltd. revealed on Saturday that the U.S. Food and Drug Administration (FDA) has issued a warning about standards at its factory in Halol, Gujarat.
This stems from an inspection of the facility in September 2014, and indicates that the U.S. regulator is dissatisfied with remedial measures the company has implemented since then.
Inspectors raised concerns last year about how workers at the Halol factory handled quality-test data and the plant’s sterile environment, the Wall Street Journal reports.
Sun Pharma said in a statement that it responded to the original FDA 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.
Commenting on the warning letter, Sun Pharma’s managing director, Dilip Shanghvi, said: “While our team is working hard to ensure that the commitments made to the U.S. FDA in September 2014 are fully completed, we will continue to cooperate with the U.S. FDA and undertake any additional steps necessary to ensure that the U.S. agency is completely satisfied with our remediation of the Halol facility.
“Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market. We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications.”
Sun Pharma will respond to the warning letter with a detailed plan.
The FDA could ban imports from the plant if the problems are not properly resolved.