FDA Inspections: Hope is Not a Strategy

Steve Schultz and Doretta Slater

The FDA inspection process is a cornerstone of the agency's mission of ensuring safety and efficacy in medical products. Being prepared for inspections helps build a culture of safety and compliance within an organization. And it's simply good business; preventing problems is less costly than remediation, after all. Of course, inspection preparedness also makes it easier for FDA personnel to do their jobs of accessing information and assessing compliance. 

While internal audits are a key component of inspection preparedness, they tend to be informal, less intense, and more focused on auditing than inspecting. True inspection preparedness supplements internal audits with a practiced inspection process and focused behavioral training for key personnel.

Before an inspection occurs, organizations should have an inspection process in place and conduct mock inspections. Like any process, inspection readiness needs a plan that is executed, assessed, and continuously improved upon. 

An overview of the roles and responsibilities for organizations appears below: 

The Inspection Room (Front Room) 
While inspectors often walk the facility, the inspection room provides a meeting space to review documentation and answer questions from the inspectors. In this "front room," system owners or subject matter experts (SMEs) review and present materials to the FDA inspector. 

The Control Room (Back Room) 
The control room provides the documentation, interviewees, and preparation that is needed to support the inspection process. This "back room" team processes requests for information, retrieves documents from electronic systems, and also triages documents as needed. The control room is staffed with quality and technical personnel who log requests for information and alert department heads within the organization. 

Control room personnel should always:

Some organizations appoint runners to take the data back and forth between the control room and the inspection room. There are technology solutions to operationalize the inspection process as well. 

Behavioral Training
In the past, employees were often trained to give curt answers to FDA inspectors to avoid inadvertent revelations to the agency. This approach created fear and mistrust among employees, and set up adversarial relationships with FDA staff. In order to create the most beneficial inspection process environment, however, both the agency and the company need to form a partnership. 

Key behavioral tips for success include:

Practicing the inspection process, however, can be one of the best ways to help employees learn appropriate behaviors and response techniques. Train employees to:

Mock Inspections
Many companies conduct internal audits as part of their inspection readiness strategies. Mock inspections, however, take the next step and allow companies to actually practice the inspection room, the control room, and inspector interaction. 

During mock inspections, organizations set up inspection rooms and control rooms to help teams learn how to readily access documentation that would potentially be requested during an inspection. Additionally, these practice sessions give employees an opportunity to demonstrate proper behavior and interviewing techniques when working with the agency. 

A mock inspection can also be used to probe further on issues uncovered during internal audits. The mock Inspection team should bring in SMEs and other personnel as needed for this activity. This approach helps the organization fully understand areas needing improvement, and gives them a platform to take corrective action before the agency actually arrives.

Being properly prepared for inspection ensures that the inspection process will run smoother, decreases the likelihood of observations, and helps groom the organization and individuals for higher levels of future performance. 

Learn more about inspection preparedness during the related session, "How to Audit-Proof Your Processes and Effectively Prepare for an Inspection," at MD&M West on February 11. Also, hear Andrew Harrison, vice president and general counsel for Regulatory Compliance Associates, weigh in on "Rebooting Your CAPA," during a panel discussion on February 10.

Steve Schultz is a principal at Regulatory Compliance Associates Inc. He can be reached at [email protected].

Doretta Slater is the director of compliance assurance at Regulatory Compliance Associates Inc. She can be reached at [email protected].

[Image courtesy of Regulatory Compliance Associates]