Benchmark FDA inspection outcomes by country. NAI / VAI / OAI mix, OAI rate, and observation density across 13,000+ inspection cycles.
Across 2,068 FDA inspections of Indian plants, 178 were classified OAI: an 8.61% rate, 1.44x the US benchmark of 5.96%. China runs below the US at 4.24% on 1,014 inspections. Germany is the cleanest top-10 cohort at 1.19% on 84 inspections. Country-level OAI rate is the first quality filter before any plant-level qualification.
Country and trailing-window filters. Default is the FDA-coverage top thirteen jurisdictions across the full catalog.
Inspection-class mix per country, OAI rate, observation density, and trailing-24-month trend. Ranked side by side with the US as the home-jurisdiction benchmark.
Citation-anchored benchmark sheet with the inspection mix per country, the rate vs benchmark, and a recommendation chip for the buyer's qualification protocol.
Proportion of inspection cycles closing as OAI. The single most compact comparative signal across jurisdictions.
Full-catalog and trailing-24-month views. A country's 5-year OAI rate may differ from its recent rate; the trend chip captures the direction.
Average 483 observations per inspection cycle. A high-OAI country with low observation density indicates concentrated severity at the failing plants.
Compounder, OTC, API, and fill-finish inspections behave differently. The benchmark can be filtered to the programme that matters to a buyer's qualification decision.
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pharmagraph_query Top thirteen jurisdictions by FDA inspection cycle count · OAI rate shown (×100 for heatmap scale) · live warehouse.
The country benchmark is the comparative inspection lens on top of the per-plant feeds. PharmaDB resolves every inspection to a country, aggregates classification mix per country, and computes OAI rate and observation density. The view is inspections joined to plants grouped by country. Refresh cadence is weekly.
Two reasons. First, FDA inspection pressure on Indian sites has been historically high, especially on plants exporting API and finished pharma into the US. Second, the OAI calibration has tightened over the last decade as data-integrity findings became more common. The benchmark is a regulator-pressure signal, not a quality verdict.
Both matter. OAI rate measures cycle outcomes; observation density measures finding intensity. A high OAI rate with low observation density indicates a small number of catastrophic plants; a low OAI rate with high observation density indicates broadly imperfect but not failing plants.
The FDA inspection feed is pulled weekly. Cycles publish on a two-to-four-month delay from the close date; the benchmark refreshes with each publication. Country aggregates are point-in-time and citation-anchored to the publication date.
The headline is FDA. The companion view covers EMA, EDQM, MHRA, PMDA, and other regulator outcomes per plant. The cross-regulator benchmark is a separate view because each agency calibrates differently.
Yes. Compounder, OTC, API, and fill-finish inspections behave differently. The benchmark can be sliced to the programme that matters to the buyer's qualification decision.
Across the top thirteen jurisdictions the FDA OAI rate has been roughly flat with a slight rise in India and a slight fall in China. The benchmark refreshes weekly and surfaces the trailing-window delta as a chip on each row.
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