If you have received a food safety-related letter from the U.S. Food and Drug Administration (FDA) requiring an immediate response, then the battle-proven advice in this article will be extremely helpful. If you are worried about receiving such a letter, then this article will be helpful in getting your organization better prepared. And if you think your organization will never get such a letter, then think again and read on.
This article offers proven suggestions on how to respond to an FDA Form 483, Warning Letter, or other similar regulatory correspondence. The objective is of course to address all of FDA’s concerns yet more importantly to aid in the management and improvement of your company’s food safety process. Responding to an FDA letter is very critical, carries the weight of law, has a very tight timeline for a response, and becomes public record. The outcome needs to be a response that is swift, substantive, and sustainable. The suggestions in this article are based on the many diverse interactions the author has had with both FDA and the U.S. Department of Agriculture and assimilate the learnings that came out of much trial and error, anger, stress, and success.