For Cause or
Not For Cause

For cause, or not for cause… that is the question. The FDA conducts three (3) types of inspections of sponsors of FDA-regulated products and devices; a inspection once a company submits a new application to market a new product, routine inspections of a regulated entity, and “for-cause” inspections to investigate issues that have come to FDA’s attention. The purpose of all three (3) is to verify compliance with relevant regulations.

Common reasons
for a “for cause” audit include:
  • Specific complaints to the FDA
  • Concerns about Stakeholders involved in the research process
  • Significant issues or termination identified during research activities
  • Multiple deviations
  • FDA identified events of special interest

“For-cause” inspections can be particularly stressful on all individuals involved, so it is best to take a proactive approach and ensure that you are always prepared for a visit by the FDA. There are several ways to ensure you are prepared for both announced and unannounced inspections, including conducting regular trainings on best practices for staff and staying up to date on the current regulations/guidelines/expectations.  Teams should identify key roles and responsibilities for company personnel and establishing a contact tree if an inspector were to arrive at your facility unexpectedly.

Not only should all parties strive for compliance, but also for showing off quality implemented throughout the work.  You can do this by maintaining up to date documentation, developing an effective and robust quality management system (QMS) and implementing a thorough inspection readiness program.

A gap analysis is an excellent way to identify gaps and weaknesses in procedures and documentation as well as highlight areas for training.  The best way to ensure that your firm is inspection ready at all times is to be proactive in preventing “for-cause” inspections and make the reactive approach the “not to be”.