|Sun Pharmaceutical Managing Director Dilip Shanghvi|
An FDA Form 483 for the inspection of a plant in India noted employees who were falsifying test results, dirty bathrooms and a laboratory that seemed uncleanable. The observations could have come right out of the warning letter sent last year to two plants operated by India's Ranbaxy Laboratories. Instead, they were the product of an inspection of a Sun Pharmaceutical plant, according to an inspection report obtained by Bloomberg.
Sun Pharma has a deal to buy Ranbaxy for $3.2 billion, and Sun Pharma Managing Director Dilip Shanghvi has said his top priority is to finally fix the long-running regulatory issues that resulted in Ranbaxy pleading guilty to felony charges last year and paying $500 million in penalties. The problems continue to plague the drugmaker, and the FDA has banned two of its plants since then. Shanghvi said he wants to get those two as well as another couple of Ranbaxy plants currently banned by the FDA from the U.S. market back in compliance. But according to a Form 483 that Bloomberg obtained through a Freedom of Information request, a Sun plant in Karkhadi displayed much of the same bad behavior as the Ranbaxy facilities the company says it can reform.
The inspection noted sanitation issues at the Sun plant that included nasty bathrooms and a lab that appeared "uncleanable." But more importantly, employees at the Sun facility routinely disregarded batch failures and simply retested drugs rather than figuring out what was at issue. They would then delete from systems the tests that didn't meet specs. The FDA placed the Sun cephalosporin antibiotics plant on its import alert list in March, but this is the first indication of why.
Sun told Bloomberg in an email that, "In this process, we have learnt and have resolved to work on further strengthening our systems and controls." It has also pointed out that the plant accounts for only about 1% of its revenues.
Sun's practice of discarding failed tests is almost exactly the same issue the FDA noted before it banned Ranbaxy's active pharmaceutical ingredient plant in Toansa in January.
That plant was the second Ranbaxy facility the FDA banned within the last year and the fourth of 5 FDA-approved plants the Indian drugmaker operates that have now been blocked. Issues with analytics were noted in some of those other actions as well. It seems to be an issue that is prevalent throughout the Indian industry: Analytic problems were also noted in warning letters the FDA sent to two Wockhardt facilities that it had banned and appeared in other regulatory actions against Indian facilities, including one operated by Germany's Fresenius Kabi.
Cleanliness was also a problem that the inspectors brought up throughout the inspection of the Sun plant, Bloomberg reported. They noted a strong aroma of urine in a quality-control lab area and bathrooms that they described as in "total disrepair." In one, they observed what appeared to be human waste on a wall. Manufacturing waste, old equipment and other garbage were noted in the "perimeter manufacturing areas" which inspectors said could attract pests. Inspectors had made similar observations at Ranbaxy's Toansa and Mohali plants, noting an analytics lab full of flies and toilets that lacked running water.
Sun told Bloomberg that it has implemented corrective measures on cleanliness at the plant. It said it has taken the "necessary disciplinary action" and replaced equipment tied to the testing failures. The drugmaker said some of the FDA's observations were related to the surrounding areas of the buildings, and it hasn't made a final decision on whether to shutter the facility.
- read the Bloomberg story