Methodology · v3.1

FWL5Warning letter FDA

FDA Warning Letters / EMA / AIFA / PMDA regulatory letters issued to {legal_name} in the last 5 years. EXTRACTION RULES: NEGATIVE-SIGNAL, SUSPICIOUS-ON-ZERO. Search ALL of: FDA Warning Letters database (fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters), EMA referrals (ema.europa.eu/en/medicines/human/referrals), AIFA provvedimenti (aifa.gov.it), PMDA notices. Return type="enumerated_events" (each: date+url+severity+description with regulator + finding). MANDATORY URL on regulator host. ZERO-EVENTS IS NOT AUTO-95: returning an empty array does NOT auto-produce the top score — the server treats this index as suspicious-on-zero and will VERIFY/RETRY a clean record rather than publish 95. So only conclude "no letters" AFTER you have actually searched EACH named register above; in _reasoning state which regulator hostnames you queried over the explicit 60-month window and that NO action was found. Never return [] out of uncertainty or because one register was hard to read. N/A PATH: if {legal_name} verifiably has NO products authorised in any FDA/EMA/AIFA/PMDA-regulated market (outside those jurisdictions entirely), return type="absent" reason="no_company_specific_data" (clean not_applicable) instead of an empty-events score.