Bausch and Lomb issues recall - FINALLY!

On May 16, four weeks after declaring that ReNu with MoistureLoc is "as safe and effective as anything on the market," Bausch and Lomb decided to recall this product throughout the world. We first found out when we saw a full page ad in USA Today and the Wall Street Journal. (Wonder that those ads cost? Think more than the cost of providing some quality GMP training? We also saw a television ad featuring Bausch and Lomb's CEO explaining the recall on May 21 during evening prime time hours on a major network - $$$$$)

Do you suppose their decision to issue a recall had anything to do with the eleven-page FDA 483 they received from FDA on May 15?

Read the FDA 483 Bausch and Lomb received from FDA at http://www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles.

Training Tip

Use this example in your GMP training sessions to demonstrate what could happen when not following GMP. Send this FDA 483 to your senior management with a note posing the following question. "Which is more expensive - Conducting effective GMP and job skills training or managing a recall?

FDA’s inspection was from March 22 to May 15. Think the stress level was up at Bausch and Lomb during that time?

Do you think this will impact consumers' confidence in Bausch and Lomb? Stay tuned.

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