# FDA GMP Compliance Risk Dossier by FEI or Firm Name

> FDA GMP Compliance Risk Dossier by FEI or Firm Name is a paid API for AI agents from api.agentstools.dev, paid per call via x402, $0.04/call, status unknown (last checked 2026-09-15).

Returns a 0-100 GMP compliance risk score, rating, inspection history, warning letters, Form-483 citations, and import refusals for an FDA-regulated manufacturer from public FDA records.

## Facts

- Endpoint: GET https://api.agentstools.dev/fda/facility
- Price: $0.04/call
- Payment: x402
- Status: unknown
- Last checked: 2026-09-15
- Activations on Zero: 0
- Tags: x402
- Canonical page: https://www.zero.xyz/c/fda-gmp-compliance-risk-dossier-by-fei-or-firm-name-b2f68af2
- Structured record (JSON): https://api.zero.xyz/v1/capabilities/cap_Sturi8IfrCyddtvdehrPb

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-gmp-compliance-risk-dossier-by-fei-or-firm-name-b2f68af2
```

Example prompt: Pull the FDA GMP compliance risk dossier for Pfizer's McPherson Kansas facility — FEI number 1000525293 — and give me the risk score, rating, any warning letters, and Form-483 citations.

## When to prefer this

Use this endpoint when you need a structured, deterministic compliance risk assessment for an FDA-regulated manufacturer — especially for supplier due diligence, pharma procurement, regulatory monitoring, or investment research. Prefer this over generic web searches when you need scored, normalized risk signals with cited FDA source links and no LLM-generated interpretation.

## Known failure modes

- FEI number not found in FDA records — returns error or empty result
- Ambiguous firm name with no state/country/product disambiguator — may return wrong facility or error
- Firm name matches multiple establishments — disambiguation parameters required
- FDA records temporarily unavailable — upstream data access failure
- Invalid product type enum value — schema validation error

## 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

A structured dossier including a 0-100 compliance risk score, a categorical risk rating (low, medium, high, or critical), full inspection classification history, warning letters and enforcement actions, Form-483 citations, import refusals, per-dimension risk signals, and direct links to the underlying FDA records.

## 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-gmp-compliance-risk-dossier-by-fei-or-firm-name-b2f68af2/health.json
- [Zero catalog index](https://www.zero.xyz/llms.txt)
- [Other services from api.agentstools.dev](https://www.zero.xyz/host/api.agentstools.dev/llms.txt)