For those of you in the business of manufacturing medical devices or pharmaceuticals, you know all about the importance of following FDA regulations. If, after an FDA audit or inspection, you are found to be out of compliance, you could receive a Warning Letter or an Untitled Letter.

An Untitled Letter is basically a way of citing a violation that does not meet the threshold of regulatory significance for a Warning Letter. A Warning Letter is the most serious of FDA letters, but it’s important to note that it’s not a form of FDA enforcement action. Instead a Warning Letter is just as the name suggests – a ‘warning’ that, if certain corrections or changes are not made, the FDA could take further action.

The intention of the letters is to bring about voluntary compliance without committing the FDA to taking enforcement action. Although there is no immediate enforcement on the part of the FDA, they do expect recipients to make the necessary changes and voluntarily comply with the law. Since Warning Letters are made public under the Freedom of Information Act, it can be helpful to review warnings given to others in an effort to avoid making the same mistakes.

If you do receive a Warning Letter, there is normally a short window (typically 15 days) in which to issue a response to the FDA. The response should include:

1. the steps that have been or will be taken to correct the violations and prevent similar violations;
2. the timeframe within which the corrections will be completed;
3. any reason the corrective action has not been completed within the response time; and,
4. any documentation that shows that correction is complete.

The amount of change that needs to take place to ‘close out’ a warning varies depending upon the violation. If the Warning Letter is in reference to misleading promotional activities, it could be as simple as discontinuing the use of an ad campaign. If, on the other hand, the violation has to do with the manufacturing process of a drug or medical device, there could be a long list of corrective actions that need to be taken. And it may take some time to address them all. In these cases the FDA may decide to withhold certain types of approvals until the issues have been rectified.

Once the violations have been corrected, a Close-Out Letter is issued. This is the official acknowledgement from the FDA that the violations outlined in the Warning Letter no longer exist.

We’d like to hear about your experiences with FDA letters. Have you ever received a Warning Letter? How long did it take before the issue was ‘closed out’?