First, they need to realize that an FDA-483 represents an investigator’s observations regarding deviations from
the GMP regulations. This requires a thoughtful and thorough response. Second, they need to take those observations seriously because a Form 483 usually lists symptoms of underlying systemic problems — problems that need to be addressed with care and consideration. Don’t be too quick to just fix the symptom, but try to find out what the underlying problem is. Instead of being too defensive, try digging deeper. A written response that reflects this degree of consideration, and provides for meaningful solutions within appropriate timeframes, is generally very well received by the agency.
However, I should note that if a company is in complete disagreement with the investigator’s observations, from a
technical or scientific standpoint, then the FDA has a formal dispute resolution program to handle that type of
situation. Of course, it is always best to try and resolve such disagreements with the investigator during the course
of the inspection.
