of the number of observations, as of September 2009. While a response is not compulsory, a good response can usually help a company avoid receiving a Warning Letter from the FDA, withholding of product approval, or plant shut-down. Most experts warn that responses should be comprehensive, well-reasoned, well-documented and timely, and that each observation should be addressed individually.

The FDA encourages resolution of issues through informal mechanisms prior to the issuance of a 483. After