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.
6 Comments
Wow what a crazy story! Pharma manufacturing is supposed to have high standards and quality control. I guess only the best manufacturers comply with these and do stability studies and such.
Is it unusual for an FDA Warning Letter to be written to a member of the co.'s Board of Directors?
Also, as I understand it the FDA is not normally allowed to pick up drugs at pharmacies that have gone through our secure distribution chain and not allowed to test patient samples that are stored in real life circumstances by ordinary people. In some states, state pharmacy board inspectors are not allowed to pick up drug samples from pharmacies or patients and send them out for testing. These samples are often destroyed or returned for destruction.
It seems like this leaves a big chunk of our pharmaceutical supply chain pretty much unregulated....if these bottles were imploding in sample rooms, what happened when they were in distribution? Would the same thing...imploding have occurred when the drugs were removed from the manufacturers packaging and put into pharmacy bottles? What about mail order?
Carter-Wallace has/had a plant in Cranbury that makes Trojan brand condoms. I hope that there was no collateral damage.
In the history repeats itself category, does anyone recall the name "Able Laboratories?" This NJ generic company folded under severe quality problems that unfolded in 2005.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150544.htm
And who bought their assets and restarted operations under their own name - why, SUN PHARMACEUTICALS ...
http://www.wellsphere.com/general-medicine-article/whatever-happened-to-able-laboratories/460485
Wow what a great information?, well an indian company making some name does some eyebrows go skywards! and u peoples start to hate them. but it doesn't taunt us anyway?