Are You Prepared for an FDA Inspection?

Eric Pittman, Director of Bioresearch Monitoring Division (West), U.S. FDAFDA

Eric Pittman, Director of Bioresearch Monitoring Division (West), U.S. FDA

Nearly half of attendees polled at the ACRP 2021 virtual conference yesterday (September 16) were either only “somewhat” (36%) or “not at all” (9%) prepared when the U.S. Food and Drug Administration (FDA) called to say an inspection was coming. The result wasn’t overly surprising to speaker Eric Pittman, director of the agency’s Bioresearch Monitoring (BIMO) Division (West).

“That’s why we do these sessions,” Pittman said, noting he and other colleagues are committed to connecting with the clinical trial industry at conferences and forums in a concerted effort to improve trial quality.

“Compliance is important to me for three reasons,” Pittman said, noting he has a wife and two daughters. He wants “to protect the public health,” starting with those three closest to him personally, he told attendees. “Someday, my wife or my children” may need the treatments or devices vetted by clinical trials, he said.

Further, Pittman’s poll found an FDA inspection is more than an abstract idea for many. In fact, more than half of those attending (57%) had been involved in an agency inspection.

Pittman offered up several tips for how to better prepare for an inspection before the FDA arrives, including:

  • Have the appropriate staff designated and available to work with the inspector.
  • Provide training to staff on regulatory requirements, specific protocol requirements, and any other relevant processes or procedures.
  • Facilitate open communications.
  • Focus not just on the “what” of compliance, but consider the “why” as well.
  • Assume all studies conducted will be inspected.

Pittman offered several other tips to encourage putting procedures in place for how to handle an inspection. Consider the use of mock inspections with staff and use sponsor audits, or other internal audits, as a tool, he said.

Another important point from Pittman: “When an investigator calls, know to whom to route them.”  Putting an FDA inspector through a series of voicemails, or being slow to respond to document requests, can raise red flags. “If it will take you time to find a document, just tell us,” he said. Otherwise, wheels in the FDA inspector’s mind can begin turning, and that’s not usually a good sign for the regulated entity.

Pittman also encouraged attendees to take a deep dive into BIMO’s Inspection Metrics on the FDA website and suggested reading posted Warning Letters. “There’s good information there” to help stakeholders better understand what FDA is looking for and how to remain in solid compliance, he said.

Author: Michael Causey