Work with the FDA to Resolve Any Issues as Efficiently as Possible

This list of ‘Inspectional Observations,’ also called an FDA Form 483, can be used by your firm's management as a guide for corrective action, since the FDA representative will not usually recommend specific corrective measures. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.”

While companies should challenge any misguided allegations of noncompliance, they should also keep an open mind to remedying any valid issues the FDA’s agents identify. Doing so promptly—and in collaboration with the FDA when warranted—can prevent inspectional observations from going from bad to worse.

It is imperative to work with the company’s FDA compliance counsel at this stage as well, as the FDA expects companies to develop their own corrective measures in the majority of circumstances. Ultimately, the goal is to receive the FDA’s seal of approval, and company leaders need to keep this in mind before, during, and after the inspection process. Get more