An Eye-Popping Warning Letter - August 27, 2007

Sometimes you read a Warning Letter that makes your eyes pop out. Here are excerpts from one such letter recently issued to a manufacturer of contact lenses.

• The change control procedure, among others, remains unsigned and undated. Changes were observed having been made via the addition of "post-it" notes.
• No record accompanies each pair of lenses nor is a record created concurrent with each step of production.
• No audits have been performed since your firm began manufacturing in 2000.
• No acceptance procedures for finished devices have been established and device history records do not include documentation of a final review to assure lenses are manufactured in accordance with device master records.

Read the entire Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down. Look for
Crystal Reflections International Warning Letter June 14, 2007

Training Tip
Use Warning Letters in your GMP training sessions as a way to learn from other peoples’ experience (OPE).

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