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| Sun Pharma headquarters in Mumbai, India--Courtesy of Hemant Mishra/Mint |
A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash.
The letter says inspectors found problems with testing and record shenanigans in the plant operations for making active pharmaceutical ingredients and finished drugs. It says when Sun was made to investigate problems, it uncovered 47 instances of apparent "trial injections" and results deleted from systems. It says at least some of the batches for which out-of–specification (OOS) results were first noted ended up being shipped to the U.S. anyway.
The revelations come just weeks after Sun Pharmaceutical announced a $3.2 billion deal to buy the long-troubled Ranbaxy Laboratories, India's largest generic drugmaker. Sun executives have said that its first priority once the deal closes is to get on top of problems that led the FDA to ban four of Ranbaxy's plants from shipping products to the U.S. But a warning letter posted by the FDA today shows that the Sun plant in engaged in some of the same kinds of data manipulation that got Ranbaxy into so much trouble that it last year paid $500 million and agreed to plead guilty to 7 felony charges.
The FDA in March issued an import alert against the plant in Karkhadi in Gujarat, India. The drugmaker at the time said the plant accounted for only about 1% of its sales in the U.S. and so the impact would not be great. But the problems are particularly important given that Sun will need FDA buy-in on whatever improvements it intends to make at the Ranbaxy plants. 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.
And at this point, the FDA is none too impressed with Sun's practices. It said the problems uncovered by inspectors, "suggest a general lack of reliability and accuracy of data generated by your firm's laboratory, which is a serious cGMP deficiency that raises concerns about the integrity of all data generated by your firm."
- here's the warning letter