{"uid":"cap_5mDC96MFP2lfn_tevJicB","slug":"fda-facility-gmp-compliance-risk-dossier-d74ee1f1","name":"FDA Facility GMP Compliance Risk Dossier","description":"GMP compliance-risk dossier for an FDA-regulated manufacturer from public FDA records. Give an FDA FEI number or firm name and get a 0-100 compliance risk score, a low, medium, high or critical rating, the inspection-classification history, warning letters and enforcement actions, Form-483 citations and import refusals, per-dimension signals and cited FDA record links. Deterministic, no LLM. Risk indicators, not legal or regulatory advice.","url":"https://payai.agentstools.dev/fda/facility?utm_source=zero.xyz","method":"GET","headers":{},"bodySchema":{"type":"object","$schema":"https://json-schema.org/draft/2020-12/schema","required":["input"],"properties":{"input":{"type":"object","required":["type","method"],"properties":{"type":{"type":"string","const":"http"},"method":{"enum":["GET","HEAD","DELETE"],"type":"string"},"queryParams":{"type":"object","properties":{"fei":{"type":"string","description":"FDA establishment identifier (FEI number); the join key"},"name":{"type":"string","description":"Firm name (used to resolve an FEI if no fei is given)"},"state":{"type":"string","description":"Optional 2-letter US state code to disambiguate a name"},"country":{"type":"string","description":"Optional country name to disambiguate a name"},"product":{"enum":["Drugs","Devices","Biologics","Foods","Cosmetics","Tobacco","Veterinary","Radiological Health"],"type":"string","description":"Optional FDA product type to disambiguate a name"}}}},"additionalProperties":false},"output":{"type":"object","required":["type"],"properties":{"type":{"type":"string"},"example":{"type":"object"}}}}},"responseSchema":null,"example":null,"exampleRequest":null,"tags":["x402"],"displayCostAmount":"0.04","displayCostAsset":"USDC","priceDynamic":false,"priceHint":null,"priceStatus":"priced","priceSource":"probe","requiresHandshake":false,"reviewCount":0,"rating":{"score":"0.00","successRate":"0.00","reviews":0,"stars":null,"state":"unrated"},"availabilityStatus":"unknown","priceObserved":null,"sessionDeposit":null,"pricing":{"kind":"static","summary":"$0.04/call","primary":{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.04","per":"call","confidence":"exact"},"accepted":[{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.04","per":"call","confidence":"exact"}]},"paymentMethods":[{"uid":"pm__dhuaV6Jjg9PFJoMAN82h","protocol":"x402","methodType":"crypto","chain":"base","mode":"charge","costAmount":"0.04","costPer":"request","priority":0,"asset":"0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913","unit":"request","depositMicros":null,"planRef":null}],"brandName":null,"brandSlug":null,"brandBaseUrl":null,"brandDocsUrl":null,"whatItDoes":"Returns a 0-100 GMP compliance risk score, risk rating, inspection history, warning letters, Form-483 citations, and import refusals for an FDA-regulated manufacturer based on public FDA records.","exampleAgentPrompt":"What's the FDA GMP compliance risk score and inspection history for Pfizer's Kalamazoo manufacturing site — can you pull the warning letters, Form-483 citations, and overall risk rating using their FEI number or firm name?","exampleUseCases":[{"title":"Supplier due diligence for pharma procurement","prompt":"I'm evaluating a drug contract manufacturer called Recipharm AB in Sweden — can you get me their FDA compliance risk score, inspection classification history, and any warning letters or import refusals on record?"},{"title":"Medical device maker regulatory risk check","prompt":"Pull the FDA compliance dossier for Boston Scientific's Maple Grove facility — I need the 0-100 risk score, risk rating, and any Form-483 observations or enforcement actions they've received."},{"title":"Food manufacturer import safety assessment","prompt":"We're considering a Chinese food ingredient supplier — look up their FDA import refusal history and GMP compliance risk rating using firm name 'Qingdao Haida Aquatic Products' and country China, product type Foods."}],"resultDescription":"Returns a structured dossier containing: a 0-100 numeric compliance risk score, a categorical risk rating (low/medium/high/critical), full inspection classification history, any warning letters and enforcement actions, Form-483 observation citations, import refusal records, per-dimension compliance signals, and direct links to cited public FDA records. All data is sourced deterministically from public FDA databases with no LLM inference.","failureModes":["FEI number not found in FDA database — returns empty or 404 response","Firm name matches multiple facilities — disambiguation requires state, country, or product type parameters","Firm name not resolvable to an FEI — may require exact name match as registered with FDA","Newly registered facility with no inspection history — score may be limited or unavailable","Non-FDA-regulated entity queried — no data returned"],"whenToPreferThis":"Use this endpoint when you need a structured, deterministic compliance risk assessment for a specific FDA-regulated manufacturer using public FDA records, especially for supplier due diligence, regulatory monitoring, or risk scoring workflows. Prefer this over manual FDA database searches or LLM-based regulatory summaries when you need scored, citation-backed output with enforcement history. Best when you have an FEI number for precision, or a firm name plus disambiguating filters.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-10-12T12:50:16.162Z","isFirstParty":false,"canonicalSlug":"fda-facility-gmp-compliance-risk-dossier-d74ee1f1"}