Thursday, September 2, 2010

Sun Pharma And Its Incredible, Imploding Bottles

Ed Silverman in Pharmalot, blogs about an unusual and severe case of a company suffering from poor GMP and quality control due to overseas manufacturing...
imploding bottles of pills.

As usual Silverman’s excellent blog enlightens by stating:

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. 25 warning 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.

Apparently the drugs are manufactured overseas and clearly Sun Pharmaceuticals has a significant quality control issue. Not to mention an issue with the dispensers and consumers that have this product on their shelf.

It is especially troubling that Sun Pharmaceuticals seemed aware of this issue but did little to correct it or warn its trading partners and the consumer of the potential danger of the product.

This again is a cautionary tale of those within the pharmaceutical supply chain needing to protect their business and the consumer by authenticating and verifying their inventories at all stops.

Clearly no one wants to be the person that ingests this product.

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