GMP Tips - Bausch & Lomb Warning Letter - Nov 6, 2006

Earlier this year Bausch and Lomb received an eleven page 483 from FDA and recalled one of their products.

NOW - they get an eleven page Warning Letter from FDA stating that FDA's "inspection identified and documented significant Quality System regulation violations that were systemic and are relevant to all products manufactured at the Greenville, SC facility."

Read both the 483 and Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resources Articles

Read our April 18 and May 22 postings in our web portal archives to learn more about B&L's journey with FDA.

Training Tip
Use these documents in your GMP training sessions to learn from other people's experiences with FDA. (Do you suppose the stress level is pretty high at B&L these days?)

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 957 clients since 1996

Our last GMP Boot Camp in 2006 is scheduled
for November 15 - 16 in Irvine, CA. Only six seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

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