FDA Updates how it Evaluates and Inspects Human Drug Facilities

The U.S. Food and Drug Administration (FDA) published an updated version of "Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations" (ConOps 2.0). The revised document replaces the original June 2017 version.

What is the ConOps?

The ConOps is an internal agreement between the FDA's Center for Drug Evaluation and Research (CDER) and its Office of Inspections and Investigations (OII). It defines how the two organisations coordinate their work on human drug facilities.
The aim is to avoid a situation in which the application review and the site inspection run as separate processes with separate information requests. Instead, both are meant to be aligned, so that the agency can take consistent, efficient, and transparent regulatory decisions.
The original ConOps was signed in June 2017 by CDER and the Office of Regulatory Affairs (ORA), the field organization that has since been renamed OII. Its central elements were:

• Integrated teams that combined CDER reviewers with field investigators
• Consistent, transparent facility evaluations and regulatory decisions
• A commitment to send facility owners a final classification letter within 90 days after an inspection closes (a GDUFA II commitment), and to complete regulatory actions for facilities with an Official Action Indicated (OAI) status within six months
  

What has changed in ConOps 2.0?

According to the FDA's landing page and the trade press coverage of the update, the main changes are the following.

1. Alignment with the FDA reorganization, reflecting the October 2024 reorganization, in which ORA became OII.
2. Remote Regulatory Assessments (RRAs) are formally part of the framework.
3. Inspection reports from Mutual Recognition Agreement (MRA) partners count as evaluation inputs.
4. Clarified roles and responsibilities.
5. Restated objectives

The document now lists five objectives:

• a risk-based approach to evaluations, inspections, and decisions;
• strategic alignment of CDER and OII functional units;
• greater operational capacity through less duplication;
• better quality of and access to facility information across FDA;
• meeting user fee commitments (PDUFA and GDUFA) with shorter regulatory timelines.

The document also sets out concrete internal timelines: for Preapproval Inspections, Postapproval Inspections, Surveillance Inspections and For-cause Inspections.

What it means for manufacturers

The changes point in one direction: FDA expects to evaluate sites with more information sources, and not only through on-site inspection:

• Expect remote requests: Records requests and virtual walkthroughs may become part of application assessments and surveillance.
• Treat MRA-partner inspections as FDA-relevant: An inspection by an EU or UK authority can now directly shape FDA's view of a site.
• Keep the site dossier and data integrity under control: The ConOps remains risk-based. A facility's compliance history, the quality of its application data, and its overall risk profile will continue to determine whether FDA inspects, assesses remotely, or relies on other evidence.
• Include CMOs and CDMOs: Contract manufacturers should be held to the same inspection-readiness expectations as the sponsor's own sites.