How's this for unusual? Over the course of a three-month inspection earlier this year, FDA inspectors found something interesting at the Sun Pharmaceuticals plant in Cranbury, New Jersey - imploding bottles. The spectacle prompted the agency to issue an Aug. 25warning letter to the Indian drugmaker that its facility is, essentially, out of control and, therefore, violating good manufacturing practices.
To wit, the FDA noted that Sun Pharma was aware last September that bottles of Gemfibrozil tablets, which are used to regulate cholesterol and triglycerides, were imploding in its sample room, but did nothing about the problem until the agency showed up this past March. There was no field alert issued. There was no recall until March of this year. And there was no explanation as to why Sun failed to investigate until the FDA arrived.
Not surprisingly, this led the FDA to write - with a bit of understatement - that Sun's process for manufacturing Gernfibrozil tablets "is not in a state of control and is not capable of producing batches of consistent quality." For now, Sun is not manufacturing the tablets, but this set of events hardly inspires confidence. Sun, after all, manufactures many generics; for instance, the drugmaker just received FDA approval to sell a copycat version of Eli Lilly's Straterra for ADHD (take a look).
Imagine if bottles of some other meds start imploding on store shelves. By comparison, that could make the musty smelling Tylenol bottles sold by Johnson & Johnson's McNeil Consumer Healthcare unit smelling like, well, roses.