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FDA Facility GMP Compliance Risk Dossier
x402
FDA Facility GMP Compliance Risk Dossier is a paid API for AI agents from payai.agentstools.dev, paid per call via x402, $0.04/call, status unknown (last checked 2026-10-12).
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.
Price / call$0.04
Success—
StatusUnknown
How this service works
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.
Output
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.
Example use cases
Supplier due diligence for pharma procurement
“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?”
Medical device maker regulatory risk check
“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.”
Food manufacturer import safety assessment
“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.”
Technical details
Endpoint
GEThttps://payai.agentstools.dev/fda/facility?utm_source=zero.xyzWhen to prefer
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.
Side effects
- 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
Input
Schema · Request body
| Field | Type | Description |
|---|---|---|
| inputrequired | object | |
| output | object |
Tags
x402
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