Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

What It Covers

Two former senior FDA executives from Canal Row Advisors — Doug Stern and Michael Rogers — analyze the deteriorating state of FDA facility inspections, covering staffing attrition, the generalist inspector shift, foreign inspection logistics, OAI classification consequences, and the agency's likely pivot toward third-party and signal-based oversight models.

Key Questions Answered

• •OAI Classification Risk: Firms classified as Official Action Indicated face compounding jeopardy as reinspection capacity shrinks. One client cited OAI classifications dating to 2018 and 2022 still unresolved, resulting in 15–20% lost market share because business partners refused engagement. Firms should treat OAI avoidance as a core business continuity strategy, not merely a compliance checkbox.
• •User Fee Fiscal Hygiene: Each GDUFA-funded investigator has roughly 950 productive annual hours legally designated for generic drug oversight. Deploying those investigators on food, device, or biologics inspections creates legal and fiscal misalignment across user fee programs. Firms should ask FDA directly how it will demonstrate that appropriated and user-fee dollars are being spent as congressionally intended.
• •Foreign Inspection Structural Limits: Unannounced foreign inspections require two investigators per site for safety, consume full weeks with no extension flexibility, and depend on support staff now reduced by the 2025 reorganization. The administration's stated goal of increasing unannounced foreign inspections cannot be achieved at current resource levels — firms with foreign manufacturing sites should prepare for longer reinspection timelines.
• •Training Infrastructure Collapse: The Office of Training and Educational Development faced cuts before 2025, and center-based training units that were meant to replace it have since been reduced or eliminated. With a concurrent hiring freeze, new investigators cannot be trained to replace departing senior national experts. Firms should assume incoming inspectors may have less program-specific expertise and prepare documentation systems legible to generalist reviewers.
• •Alternative Oversight Tools Emerging: FDA is moving toward leveraging third-party audit data, foreign government recall decisions under Section 804(a)(2) to block imports without independent FDA evaluation, and environmental signals like regional floods or sudden excipient price drops as inspection triggers. Firms should consider voluntarily sharing third-party audit results and monitoring foreign regulatory actions affecting their supply chains proactively.