Effectively Responding to FDA 483s and Warning Letters

No company wants to receive an FDA-483 or Warning Letter for adverse findings after an FDA inspection, but it does happen. If an FDA inspection yields any Good Manufacturing Practices (GMP) compliance concerns or faults during the inspection, FDA is required to fill out a report immediately. It is important to understand the purpose and scope of both FDA 483s and Warning Letters so as to be able to respond to them quickly and effectively. This lesson covers the basic principles of FDA 483s and the use of Warning Letters used by FDA to voice compliance concerns. In addition, you will recognize the significance of both these documents. You will also be able to describe the key aspects of written responses to both FDA 483s and Warning Letters.