How to Handle an FDA-483 Observation When You Don’t Agree

The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place. During the course of an FDA inspection, there will be many opportunities to ascertain the areas of interest and potential areas of concern of the investigator. The clearest opportunity to understand the true concerns of the investigator will be during the periodic wrap-up sessions, which should occur on a daily basis per Investigations Operations Manual (IOM) Section 5.2.3, writes Parexel’s David Elder and Richard Wright, former FDA officials, in the current PharmTech issue.

FDA investigators are human beings just like the rest of us and mistakes or misunderstanding can happen. The agency encourages the industry to use these communication opportunities to ask questions or request clarification, and if during the course of these communication opportunities it becomes apparent that there is an area of misinterpretation or misunderstanding, additional information or documentation should be presented quickly and clearly, they state. Read more of this answer in the October issue of PharmTech