How to Avoid a FDA Warning Letter

A warning letter from the Food and Drug Administration (FDA) isn’t something that should be taken lightly. In fact, it’s best avoided at all costs. That’s because the FDA takes its job seriously and won’t hesitate to cite your company over concerns of alleged violations. In the event that an FDA investigator arrives at your facility to ensure everything is running by the book, it’s best to be prepared for the impending inspection and demonstrate your knowledge of pharmacovigilance. This is essential because your company won’t be able to develop and market products in the US and overseas if they don’t adhere to certain standards for drug safety that are required in the US, European and Asian countries. One of the best ways to make sure everything is squared away is by hiring a pharmacovigilance consultant. If you skip this vital step, you may end up with a warning letter from the FDA.

Overall, these warning letters will describe the supposed failures and shortcomings the investigator found during their visit. Each of these issues will be explained in-depth and the reason for their significance as it applies to pharmacovigilance SOPS will be addressed. The benefit of this thorough explanation is that it shows you exactly how to fix the shortcomings and get in the FDA’s good graces once again. Otherwise, as one violation letter from the FDA reads, it’s “your responsibility to ensure compliance” and “failure to correct these violations promptly may result in legal action, including injunction, without further notice.” As those warnings make clear, it’s best to fix the problems immediately upon receipt of the FDA’s letter.