Warning Letters and your commitment to the FDA

According to the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374), the FDA is authorized to perform inspections on a regulated premises. Any compliance concerns or discrepancies are addressed by the FDA inspectors via form FD-483 or Warning Letter. It is in the best interest of the organization to respond to observations and findings in a satisfactory manner, in order to avoid the FDA taking further adversary actions against the organization.

A well organized, well documented, and timely response can prevent observations from becoming warnings, and subsequently, fines or even consent decree. An appropriate FD-483 response will address the observations made by inspectors by explaining the actions that will be taken to remedy the compliance concerns, as well as the available resources that will be used to make these corrections, and the timeline that the facility expects to have this concern corrected.

In the event that an organization decides against providing a timely response to an FD-483, they will likely be given a Warning Letter, which requires that the organization respond and explain any reasons that they were unable or unwilling to provide an adequate response to the observations noted from the inspection. In addition to explaining reasoning behind failing to address concerns noted by an FD-483, the organization must also reply with the aforementioned information for an appropriate response.

Once the response has been made, the organization is obligated to correcting the concerns within the timeline that they have committed to. Missing a commitment date is not only an unprofessional display of disinterest in compliance, but can also lead to further enforcement actions by the FDA, such as fines and consent decrees, or even facility shut down. To ensure that corrections will be made in a timely manner, employees should be notified of the observations and findings, as well as be informed of the organization’s plan to address the issues at hand. In their response, the organization management has to determine a realistic time frame in which they will be able to address the non-compliance issue, how they will address it, and by when the action items related to that issue will be implemented.

It is of utmost importance to acknowledge any observations or findings of FDA inspections in a timely manner. Organizations that thoroughly address and remedy concerns show a commitment to compliance and are able to build credibility not only with the FDA, but also with their customers who will feel assured that problems will be addressed and resolved as promised.

The best way to think about the seriousness of a commitment to the FDA is to keep in mind that the FDA already has a suspension that you are not complying with the regulations. Therefore, not meeting your commitments will simply indicate to them that you have chosen not to comply.

So, how would you feel if you were not taken seriously?