My name is Scott Loughan and I am a Compliance Officer in the Food and Drug Administration’s Office of Regulatory Affairs. I work in Vermont and I am a senior case officer in my division. It’s my job to protect the public health by working with manufacturers that FDA regulates to make sure they meet all federal laws, rules, and regulations.
To do this I review and evaluate findings and evidence collected during inspections by our FDA investigators that could indicate a possible lack of compliance with agency enforced laws, and regulations.
I also work with manufacturers to try to get them to voluntarily comply with FDA regulations. If they don’t, it’s my job to use other methods such as Warning and/or Advisory Letters, Informal Agency Hearings, and Administrative Actions to make sure they follow the rules.
When these methods don’t work I determine the most suitable public health course of action. When necessary I recommend administrative or legal actions and I work with ORA’s (Office of Regulatory Affairs) headquarters, the FDA’s Office of the Chief Counsel, and the responsible U.S. Attorney’s Office to ensure compliance. FDA may recall or detain products, which we call administrative detention, and when necessary take court actions including seizures or injunctions, to make sure that unsafe products do not reach consumers.
Since I joined FDA in 2002, I have worked on many cases. One case that I’m especially proud of is a judicial seizure that removed over 5,000 cases of ready-to-eat frozen cooked crabmeat from the marketplace in October 2015. We determined that the products had been prepared, packed and held under unsanitary conditions, which could have presented a risk to consumers.
I coordinated multiple FDA inspection teams to develop evidence to support the seizure and worked with the U.S. Attorney’s Office in Boston to present the case in U.S. District Court. Once the courts ruled in our favor, working with the U.S. Marshal Service we seized and destroyed the product to protect the public from potentially serious or deadly foodborne illness. Our New England team is very proud of this effort.
The work I do is important and focused on public health protection. I feel that I make a difference every day that I go to work helping to protect the food that we eat. I’m constantly learning something new and that keeps the work interesting and dynamic.
I have always been thankful for the day an FDA investigator who was conducting an inspection of a pharmaceutical plant where I worked took me aside and told me that he thought I should consider doing something really meaningful. He encouraged me to apply for an opening that FDA had posted on USA Jobs.
That evening I went online and applied for an FDA Import investigator position. The attacks of 9/11 had recently occurred and a short time later I was offered a position under the counterterrorism new hire initiative. The FDA investigator who encouraged me to apply for the job later became an ORA supervisor and then a compliance officer. We remain friends to this day.
I am very honored to be this year’s ORA Compliance Officer of the Year.
I am Scott Loughan and #IAmORA.
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