How these records are assembled. Generated 2026-07-16.
Every record links to its source. Three public FDA datasets feed these pages: import refusals from the FDA Data Dashboard (154,247 records since 2019 in the current pull), compliance actions from the same API (174,713 records), and import alert Red List pages (23,917 firm listings crawled from accessdata.fda.gov). FDA publishes each of these on its own schedule; each page states its generation date.
Refusals and compliance actions carry an FEI number, the identifier FDA assigns to one facility, and join exactly. Import alert listings carry a firm name and address, and attach to a facility only when the name agrees and the full address corroborates. In a hand graded census of all 148 such matches in the research cohort, 147 were correct (99.3%). Candidate matches that fail the address test are discarded rather than shown. In a separate hand check of 30 sampled alert listings, 13 of the 13 firms present in the refusal data were found by this matching and 0 were missed.
FDA records refusals line by line, so one event can appear as dozens of rows. These pages group lines into episodes when they share the same FDA charge codes within a 30 day window, and report both numbers. Counting episodes keeps one underlying event from reading as many.
Peer figures compare a facility to suppliers from the same country and FDA industry code with at least one refusal since 2019. They are observed counts and medians. Public data does not include how many shipments a firm made, so refusal rates cannot be computed, and these pages do not estimate them.
Past events do not predict future outcomes. These pages report what public FDA records show, with a link to every source. They do not evaluate whether any firm or shipment meets legal requirements, they do not score or predict, and FDA data can contain errors or later corrections. A firm's absence says only that no matching public record was found in the current data window.