Revised Drug Inspection Framework Critiqued by Attorneys

FDA's updated operating framework for drug facility inspections makes several procedural changes affecting inspection classifications, remote assessments and the use of foreign regulatory inspection reports, according to an analysis by Hogan Lovells. The revised Concept of Operations (ConOps 2.0) replaces the agency's 2017 framework governing coordination between CDER and the Office of Inspections and Investigations.

In its analysis, Hogan Lovells describes the changes as relatively modest but identified several provisions with practical implications for manufacturers. Among the changes, CDER must finalize certain preapproval inspection classifications within 45 days after receiving the complete establishment inspection report and the manufacturer's written response to Form FDA 483 observations, or by the applicable application-related deadline, whichever comes first.

For surveillance inspections, CDER now makes final determinations for both voluntary action indicated (VAI) and official action indicated classifications. Previously, FDA's field organization finalized VAI classifications. Final classification letters are to be issued within 90 days of inspection closure.

The revised framework also formally incorporates remote regulatory assessments, including records requests and interactive evaluations, across all four inspection categories, according to the analysis. FDA also clarifies how it uses inspection reports from mutual recognition agreement partners, including regulators in the European Union, United Kingdom and Switzerland. Those reports can satisfy certain routine surveillance inspection requirements and inform application decisions.

Another provision directs investigators to alert CDER's Drug Shortage Staff when inspection findings could affect drug production or distribution, and to request that manufacturers report potential production disruptions.

Hogan Lovells advises manufacturers to treat remote records requests and foreign regulatory inspections as potentially consequential FDA compliance events and to prepare timely, substantive responses to inspection observations.