Warning letters, what they are, how we can help

Posted on October 09, 2012

As discussed in our previous post, "FDA 483: your company contains critical errors," a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of serious violations, a Warning Letter is generally issued by the FDA following an extensive review of site inspection results, usually within 30 days of the inspection close out. The purpose of a Warning Letter is to notify companies that they are operating in violation of The Act, and that they are expected to remedy all outstanding issues in order to become compliant. The significance of a Warning Letter versus a 483 is that a Warning Letter is an official statement by the FDA confirming that a company is operating out of compliance, whereas a 483 is an inspector’s (highly influential) opinion on the matter, but is not an official Agency...