HDA 2024 Traceability Seminar: What to Expect From FDA Inspections

PC: You recently hosted a session on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance.” What points did you dive into during your presentation?

Hunter: We talked about a lot of in general, what the FDA is inspecting. My key for this was trying to go for people that had never seen the FDA before, such as some of these warehouses and 3PLs. They may not have seen an FDA inspector before. So, what is an FDA audit? What types of audits and inspections can happen? Some of the documentation you'll see behind it, some of the forms they might use, you can be prepared to know what to expect from them and be given by them, as well as some of the things you can do to prepare and get yourself ready for the inevitable inspection. So, things such as having a process and a procedure in place, and, more importantly, training and practicing that procedure. Processes are a dime a dozen. If you don't train on them, they're worthless.

PC: What exactly is the FDA looking for during these inspections?

Hunter: So, at its core, the FDA is looking to protect public health, and when they come in for an inspection, they're looking to see, do you have processes and procedures in place to the applicable regulations that they've implemented, and then what's the evidence you have that you are compliant and using those procedures applicably to those regulations? That's the simplest answer you can get for what they're looking for.

PC: What other session/topics at the Traceability Seminar have caught your eye thus far, and which upcoming ones are you looking forward to?

Hunter: I sat in earlier on the topic for sale-able returns and how those are going to be handled. I think that's going to be a big challenge once this is fully implemented. I think having those things in place and figured out by that time is going to be a real challenge.