Another Contact Lens Solution Recalled - May 29, 2007

Advanced Medical Optics (AMO) announced a recall of one of their contact lens solutions on May 25 because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). This could be a direct GMP issue - contamination during the manufacturing process.

Last November AMO recalled 18 batches of contact lens solutions for contamination problems. Just last week AMO said they would try to acquire Bausch and Lomb, who announced last week that they were being acquired by a private equity investment firm.

Read FDA's announcement of AMO's voluntary recall. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Perhaps the management at AMO should be focusing more energy on producing high quality products and less on acquiring competitors.

Is it just us, or is there a considerable increase in contamination issues lately?

It's a good idea to conduct an internal audit at your firm and focus on cleaning and reducing the risk of contamination.

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