Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask how they will be done—i.e., do you have the resources to do the work?

If these questions are not fully addressed in the FD483, then the FDA will ask them again in the subsequent Warning Letter, in the part where they acknowledge receipt of the firm’s FD483 response—and the inadequacy of it.

It is very formulaic and predictable.

So my first point is that there is no excuse for an inadequate response to an FD483 or a Warning Letter. There are plenty of Warning Letters on the FDA website that provide examples of poor responses and what the FDA thinks about them. There’s no excuse for not knowing how to respond.

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