In 2020, FDA on-site facility inspections cratered from 16,005 to 5,274 — a 67% collapse in a single year. But import refusals, the border-screening action FDA can issue without ever setting foot in a plant, rose from 7,713 to 10,041 over the same period. Enforcement did not simply pause during COVID-19; it relocated from the factory floor to the port of entry, and five years later the on-site side still has not fully recovered.
These numbers come from FDA's public compliance-action records spanning 2001–2026 (973,469 records), aggregated by action type and date. The index carries five action categories — inspection (267,461 records), citation_483 (264,382), import_refusal (231,115), compliance_action (171,081, i.e. warning letters and related actions), and recall (39,430) — and the year-over-year pattern is the clearest natural experiment in the whole dataset.
The mechanism: two enforcement tracks, one broken by geography
FDA's domestic and foreign facility inspections require an investigator physically present in a plant. On March 18, 2020, the agency suspended all domestic routine surveillance inspections, and from March through September 2020 it completed just three mission-critical foreign inspections worldwide, versus roughly 600 a year in 2018 and 2019. Import screening, by contrast, runs on paperwork, prior-notice filings, and automated risk models (PREDICT) that never required an inspector on a plane. That structural asymmetry is exactly what the index shows: citation_483 counts (which are issued only during an on-site inspection) fell in lockstep with inspections — 14,720 in 2019 to 4,742 in 2020 — while import_refusal kept climbing.
Recovery has been partial, and it is a staffing story now
Inspection volume climbed back after 2020 — 8,601 (2021), 12,627 (2022), 14,295 (2023) — but 2023 still sits 11% below 2019. That is no longer a pandemic-access problem; GAO's 2025 review found the vacancy rate among FDA investigators who inspect drug manufacturers jumped from 9% in November 2021 to 16% by June 2024, with drug-investigator vacancies rising from 25 to 73 over the same window (GAO-25-106775). FDA itself reported conducting 621 foreign and 444 domestic inspections in FY2023 — 36% fewer than FY2019 (The FDA Group summary of GAO findings). The agency's own manufacturing and supply-chain COVID-19 guidance and its Resiliency Roadmap both describe the shift toward remote records requests and risk-based prioritization that has persisted well past the emergency phase — a durable change in how compliance is verified, not just a temporary substitution.
What the index does not capture
Three caveats matter here. First, classification and detail fields are populated inconsistently across action types, so this analysis leans on volume, not severity (an NAI-vs-OAI breakdown would need the raw FDA Compliance Dashboard or Inspection Classification database directly). Second, import_refusal volume is sensitive to trade patterns and FDA's PREDICT targeting rule changes independent of inspection capacity, so the inverse correlation in 2020 is suggestive, not causal. Third, action_date reflects when a record was logged, which can lag the underlying event by weeks, and 2026 is a partial year (12,641 records so far) that should not be read as a full-year data point.
The practical takeaway for anyone tracking a manufacturer's compliance exposure: a clean recent inspection history is now a weaker signal than it used to be, because fewer sites are being visited at all. Screening decisions increasingly have to lean on import refusal history, 483 citation patterns at sister facilities, and compliance-action records rather than assuming "no recent inspection" means "no recent problem."