How a GMP Issue Can Take Down a Company - May 21, 2007

You may remember last May (2006) when Bausch and Lomb recalled one of its contact lens cleaning solutions (a $100 million-a-year product) because of an outbreak of potentially blinding infections. At first they denied that there was a problem with the product, but enough evidence surfaced to warrant the recall.

It is no surprise that B&L’s sales for 2006 fell significantly. In their struggle to recover, they have agreed to a buyout by a private equity investment firm. B&L was started in 1853 by John Jacob Bausch, a German immigrant, who set up an optical goods shop in Rochester, NY. He borrowed $60 from his partner Henry Lomb.

It’s a sad tale that after 154 years; a company is taken down by a contaminated product. Clearly this was a GMP issue, and could have been prevented.

Some background on this case.
We reported in April 2006 that the fungus infection problem surfaced and B&L’s CEO at that time said that their product was "as safe and effective as anything on the market." Four weeks later, one day after receiving an eleven page 483 from FDA, B&L issued the recall. Five months later, In October 2006, B&L received an eleven page Warning Letter from FDA. Now they’re being bought out. This is a classic example of what we call “the death spiral.”

We generally find the death spiral syndrome where GMP and Quality are not part of a company’s culture. Some companies “Get it” and some companies “Don’t get it.”

Sadly, for the customers and employees of B&L, their current management “Didn’t get it.”

Read the 483 and Warning Letter issued to B&L in 2006. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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