Today we have the privilege of interviewing former FDA investigator, Luis Chavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration.
1. What do you think are the biggest misconceptions about FDA inspectors?
I believe the biggest misconception about FDA inspectors is that they are there to “get you.” Almost all of the coworkers in my 30 years plus in the agency were mission-driven to stop an adulterated product from distribution. The part of “getting you” became a reality only after a company failed to act properly on the warning regarding an adulterated product that could potentially hurt a consumer.
2. How much variability from one inspector to another when it comes to level of scrutiny?
There is tremendous variability in the level of scrutiny from one investigator to another and at times, there is tremendous variability in level of scrutiny from the same investigator due to a long list of factors beyond the control of the investigator, such as work load, timing and preparation for the inspection. What does not change is the dedication to mission and to protect the consumer which causes a high degree of stress in an officer not able to accomplish what he wants and needs to do.
3. What’s the most common mistake you see people in industry make related to FDA inspections?
The most common mistake is that if your firm does not receive a Notice of Observations, you must be in a great state of “control.”
4. Do you think FDA 483s will become more or less important in the future?
I think FDA 483s will become more important in the future because it is a condensed list and is the bottom line of what has to be corrected and also, what has to be supported by evidence to make a decision to take regulatory action. The other document that accompanies the FDA-483 might also be a few pages due to uncontrolled circumstances, but the FDA-483 must document the issue at hand in a direct way with evidence linking a deviation from a regulation. This FDA document represents your company’s compliance standing with the FDA in the eyes of many. Ultimately this is the document that competitors, regulators and others want to know about.
5. What’s one thing that you wish everyone knew about FDA inspectors?
The dedication to the mission of protecting the American Consumer that is blind to politics and the price they have to pay when agency leaders and others remind them of politics.
6. FDA inspections in the US vs. FDA inspections abroad – are there any notable differences in approach or preparation?
There is a tremendous difference in both approach and preparation for US domestic inspections vs. inspections abroad. The agency’s official stance has always been that they are equal, but the field investigators and many domestic companies know better. Just ask the domestic firms that have had a portable FDA office in their facility with an army of FDA investigators coming in and out for a month or at times longer. The agency does not have the budget nor the logistical capability to support this type of activity abroad on a regular basis. The great equalizer is section 21 USC section 801 and the appearance of a violation at the border for firms abroad.
Luis Chavarria is a 30 plus year veteran of the FDA, starting as an Import Inspector, Investigator, specialist, supervisor, manager and diplomat. He now runs Supaso International LLC, www.supaso.com, an FDA regulatory consulting firm.
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