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.