Warning letter is the representation of FDA’s first official notification to a firm which FDA finds in violation or adulteration of the Food, Drug, and Cosmetic Act. Before initiating formal enforcement action, FDA, by issuing warning letter, gives an opportunity to the firm to take voluntary corrective action.
On the basis of inspection, FDA centers and district offices issue warning letters to the inspected firms mentioning the violation it found in products or in manufacturing processes that require prompt and adequate corrective actions. However, not only FDA but other centers can also issue warning letters for advertising and promotional violations in the United States.
FDA considers warning letters as the most effective compliance tool. In most of FDA’s follow-up activities, it finds that the warned firms have either corrected the violations mentioned in warning letters or have made noteworthy progress toward doing so.
General Components of warning letter
A – The person to whom it is addressed
B – The issue which is causing the compliance problem
C – The recommended remedial action and time period
Through warning letter, FDA instructs firms to rectify the issues noted and to provide responses in writing within 15 days of receipt of the letter. With the help of appropriate center, the district offices determine the adequacy of response of the warned firm. In case of adequate response, the district or appropriate center notify other appropriate agency unit and then re-inspection of the firm takes place.
As described above due to process or compliance failure the warning letters are issued by FDA after the inspection process, knowing the process failure steps which lead to a warning letter will help companies avoid it and pass successful inspection.
