GMP Tips - Effective Response to FDA 483 - August 6, 2008

Just last week a Warning Letter was issued to NeoChild LLC. In this Warning Letter FDA takes issue with several of the company's responses to the the FDA 483, List of Inspectional Observations, that they received during an FDA inspection.

This particular Warning Letter provides very specific insights into FDA's current thinking and outlines their expectations on specific issues. We recommend that you share this Warning Letter with those in your company responsible for dealing directly with the FDA during inspections.

GMP Tip
Use this letter and other Warning Letters in your GMP training to discuss specific GMP issues and whether your company may be vulnerable. Learning from other people's experiences with FDA can keep you out of trouble with the FDA.

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Please forward this to others in your organization who may benefit.