# FDA Facility GMP Compliance Risk Dossier

> 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.

## Facts

- Endpoint: GET https://payai.agentstools.dev/fda/facility?utm_source=zero.xyz
- Price: $0.04/call
- Payment: x402
- Status: unknown
- Last checked: 2026-10-12
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-facility-gmp-compliance-risk-dossier-d74ee1f1
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_5mDC96MFP2lfn_tevJicB

Status and success rate cover calls made through Zero and Zero's own probes. Third-party monitors may report differently.

## How to call it through Zero

Zero handles the 402 payment challenge and records the run. With the Zero CLI installed (`npm i -g @zeroxyz/cli`):

```sh
zero fetch --capability fda-facility-gmp-compliance-risk-dossier-d74ee1f1
```

Example prompt: 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?

## When to prefer this

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.

## Known failure modes

- 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

## 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.

## Request schema (JSON Schema)

```json
{
 "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"
    }
   }
  }
 }
}
```

## More

- Live health (JSON, refreshed every minute): https://www.zero.xyz/c/fda-facility-gmp-compliance-risk-dossier-d74ee1f1/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from payai.agentstools.dev](https://www.zero.xyz/host/payai.agentstools.dev/llms.txt)