Helpful Tip: What the FDA Investigator Might Be Looking For
It’s Monday morning and you just arrived at the plant and walked into your office. You’re looking over a Food Safety Incident report on foreign material found during the sanitation cycle over the weekend. How can this day get worse?! Then you get a call from the front desk telling you the FDA Investigator is here. Wouldn’t it be nice to know why they are here and what they’ll be looking for?
It’s a running joke that when the FDA Investigator arrives you should ask them “what was the last seminar you attended?” – the logic being that we all tend to practice what we just learned, so the investigator would tend to focus on the topic of their last training seminar and check our accompanying records for compliance. Another reaction to an unexpected visit from the FDA Investigator could be to get their name from the receptionist, race to your computer and google them, only to discover they scribbled out a 483 back in 2013 on pest control at a small plant in Jefferson City, MO, and not much more. Tempting as these frantic tactics may seem when you’re surprised by an FDA visit, they certainly aren’t practical and they’re not very professional. It’s always better to be proactive than reactive when possible, and there are better ways to know what the FDA might be focusing on when conducting inspections at your facility.
The FDA has a wealth of information available on its website (www.fda.gov) and as a person responsible for Food Safety at your company, you should visit it regularly. You’ll find helpful data on recalls and warning letters, plus other useful information on hot topics an FDA investigator might focus on. There’s a particularly useful section in the FDA’s website, but it takes a targeted search to find it. Luckily for you, we’ve already done that work for you. Here’s a helpful link: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations.
The link will take you to the Inspections Observations page, where you’ll find some helpful information about “483’s”, a tool the FDA uses to record observations during facility inspections and to report on violations of the Food, Drug and Cosmetic Act. This page shows a listing of all 483’s recorded within the last year, and you can readily see which violations are cited most often. This is incredibly useful information to help you understand what the FDA is thinking. Each 483 record gives a reference number, a short description, a long description and details of observations and more; a study of these will help you understand what investigators are citing. This inclusive list won’t tell you which individual investigator cited what, but it will give you a reliable indicator of what the FDA is concerned with holistically within food manufacturing. For example, last year a leading citation focus area was on the FSVP (Foreign Supplier Verification Program), which indicates the FDA is highly concerned with domestic food manufacturers’ management of food products sourced from foreign entities. Good information to know, don’t you think?
With so many details to consider in your food safety practices, it’s helpful to understand what areas FDA Investigators are probably focusing on at any given time, so you can proactively ensure your facility is in compliance on those critical issues. Of course, you’re always focused on ensuring total compliance in all areas, but wouldn’t you hate to get cited for something you knew the FDA investigator was probably going to look at closely?
So that’s the helpful tip: Visit the FDA website regularly to stay up on the latest information and be sure to visit the Inspections Observations page to understand where FDA Inspectors are focused. Remember, Food Safety and regulatory compliance is an ever-evolving journey subject to societal changes and new understandings in science, and the FDA website is a great resource to keep on top of critical information.