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PRSM

fda_citations

Active

Tool of FDA Data MCP

declared in 0.1.0

Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in openFDA API). Filter by company name, FEI number, CFR number, keyword, program area, fiscal year, inspection date range, or the parent inspection's classification (NAI/VAI/OAI). CFR matching is hierarchical and section-anchored: pass '21 CFR 211.68' or '211.68' and it matches '21 CFR 211.68', '21 CFR 211.68(a)', '21 CFR 211.68(b)' but NOT '21 CFR 211.680' or '21 CFR 211.6'. Each row carries the parent inspection's classification (inspection_classification / inspection_classification_code) joined by inspection_id, plus inspection_id and a best-effort source_url deep link. Returns the cited regulation, short and long descriptions of the finding, and inspection dates. Related: fda_inspections (inspection classification and dates by FEI), fda_search_warning_letters (official warning letters for the same FEI), fda_compliance_actions (warning letters that may reference these citations).

Parameters schema

{
  "type": "object",
  "$schema": "http://json-schema.org/draft-07/schema#",
  "properties": {
    "limit": {
      "type": "integer",
      "default": 100,
      "maximum": 500,
      "minimum": 1,
      "description": "Max results to return (1-500)"
    },
    "offset": {
      "type": "integer",
      "default": 0,
      "maximum": 9007199254740991,
      "minimum": 0,
      "description": "Result offset for pagination"
    },
    "date_to": {
      "type": "string",
      "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
      "description": "End date for inspection_end_date range (YYYY-MM-DD)"
    },
    "keyword": {
      "type": "string",
      "maxLength": 500,
      "description": "Keyword to search in citation descriptions"
    },
    "date_from": {
      "type": "string",
      "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
      "description": "Start date for inspection_end_date range (YYYY-MM-DD)"
    },
    "fei_number": {
      "type": "string",
      "pattern": "^\\d{1,10}$",
      "description": "FDA Establishment Identifier (FEI number)"
    },
    "fiscal_year": {
      "type": "integer",
      "maximum": 2100,
      "minimum": 2000,
      "description": "Fiscal year of the inspection"
    },
    "company_name": {
      "type": "string",
      "maxLength": 500,
      "description": "Company name (fuzzy match)"
    },
    "program_area": {
      "type": "string",
      "maxLength": 200,
      "description": "Program area (partial match, e.g. Drugs, Devices, Foods)"
    },
    "act_cfr_number": {
      "type": "string",
      "maxLength": 200,
      "description": "CFR section, section-anchored prefix match (e.g. '21 CFR 211.68' or '211.68' matches 211.68, 211.68(a), 211.68(b) but not 211.680 or 211.6)"
    },
    "classification": {
      "enum": [
        "NAI",
        "VAI",
        "OAI"
      ],
      "type": "string",
      "description": "Parent inspection classification (NAI=No Action Indicated, VAI=Voluntary Action Indicated, OAI=Official Action Indicated)"
    }
  }
}

What this tool wraps· 1 endpoint

min confidence0.700.50

Parent server

FDA Data MCP

https://github.com/medley/fda-data

1/7 registries
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