Sun Pharmaceutical Drug Plant Was Banned By The FDA

A Sun Pharmaceutical Industries, Ltd. drug plant located in India was banned from exporting products into the US after the Food and Drug Administration found onsite garbage pileup, testing flaws, and a laboratory that was described as “uncleanable.” FDA inspectors found that some lab workers had manipulated test data and eliminated undesirable results. Furthermore, rodent traps were found, and bathrooms were not in working order. A substance that appeared to be human waste was observed on a bathroom wall and there was a strong smell of urine. The plant manufactures the antibiotic cephalosporin and bulk ingredients that comprise the drug.

The Karkhadi, India laboratory yielded less than one percent of Sun Pharmaceutical’s revenue in 2013. However, the company’s stock may decline in value if violations continue to be observed. The company reported in an email that it has since implemented corrective steps at the plant to improve cleanliness, and defective equipment has been replaced. Disciplinary action has been taken in instances in which the proper testing procedure was not followed. Nevertheless, Sun has not made a final decision on whether the factory will be closed.

Over the past year, the FDA has issued approximately 20 similar bans against pharmaceutical plants in India exporting products to the U.S. The most recent ban was issued in January 2014 against Ranbaxy, where workers were found to have altered test results by overwriting raw data that had been collected on samples for more than five months. Sun agreed in April 2014 to purchase Ranbaxy despite the ban that was placed on four of the company’s laboratories.

Indian pharmaceutical manufacturers have become a major exporter to the U.S. as demand for cheaper generics has increased. These companies also provide affordable pharmaceutical products to countries in Africa. Due to several suppliers being subjected to FDA sanctions as a result of not meeting manufacturing standards, Indian pharmaceutical factories have come under great scrutiny within the past year. A spokesperson from Ernst & Young noted that the reported issues are not necessarily due to a lack of standards in India; however, drug factories can get away with violations more easily.

Reference:
http://www.bloomberg.com/news/2014-04-25/fda-banned-sun-plant-after-finding-data-flaws-rat-traps.html