If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA). With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status. With so much riding on any given inspection, what do you do if problems arise with the investigator or analyst?
This question was asked of FDA’s Office of Regulatory Affairs (ORA) senior leaders at the 120th Association of Food and Drug Officials (AFDO) Annual Educational Conference in Pittsburgh, PA. Industry members raised concerns specific to investigator behavior. The overarching theme was the fear of Agency retaliation for reporting an investigator’s conduct during the course of an inspection.
All FDA representatives present agreed that unprofessional behavior on the part of an investigator is something the leadership wants and needs to know about. Additionally, they encouraged the firm’s management to contact the District during the course of an inspection if they feel the behavior is egregious enough to warrant such, but indicated that management may wait until the close of the inspection. Officials’ clarified actions may or may not be taken immediately depending on circumstances, but all allegations of misconduct would be investigated.
As for retaliation, ORA officials reminded the audience that there are multiple layers of review. At each level, the content of the official report and FDA Form 483, if issued, are verified against the documented evidence.
Regarding delays in inspections, officials stated that there are legitimate reasons why an inspection may be delayed or prolonged, including: observation of significant deviations, prior commitments, emergency situations, or employee illness. What should not be typical is an investigator working very short days, 3-4 hours, or taking “days off” without reasonable explanation.
Specific advice for industry consisted of: keeping notes of behavior, time spent conducting the inspection and/or absences and presenting that evidence to the Agency; reporting the behavior in a timely manner; understanding that disagreements do occur during the course of an inspection; however, behavior should remain professional and policies should be followed, and, reminding everyone that investigators are only human as well, may have a bad day, or may make mistakes.
It is notable that the guiding document for FDA investigators, the Investigations Operations Manual (IOM) addresses this issue.
“The public expects exemplary behavior and conduct from the government employee.”
“You may receive complaints or other questions from the regulated industry during routine field operations…provide the firm the “Information for FDA-Regulated Industry” Website “www.fda.gov/oc/industry”. Explain there are Small Business links on the webpage and the FDA Ombudsman link is located under the Contact FDA heading, and they may also call the District Office.”
“You are expected to conduct yourself in a prudent manner, so that the work of the Agency is effectively accomplished. Your job is to gather and present the facts. Accuracy and objective observation are absolutely essential.”
The key is to open lines of communication with the District management should this situation arise.