Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in openFDA API). Filter by company name, FEI number, CFR number (e.g., '21 CFR 211.68' for a specific section, or '21 CFR 211' for all cGMP violations), or keyword in citation descriptions. Retu...
Part of the FDA Data MCP server.
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AI agents call fda_citations to retrieve information from FDA Data MCP without modifying any data. This is common in research, monitoring, and reporting workflows where the agent needs context before taking action. Because read operations don't change state, they are generally safe to allow without restrictions -- but you may still want rate limits to control API costs.
Even though fda_citations only reads data, uncontrolled read access can leak sensitive information or rack up API costs. An agent caught in a retry loop could make thousands of calls per minute. A rate limit gives you a safety net without blocking legitimate use.
Read-only tools are safe to allow by default. No rate limit needed unless you want to control costs.
{
"version": "1",
"default": "deny",
"tools": {
"fda_citations": {}
}
} See the full FDA Data MCP policy for all 48 tools.
These attack patterns abuse exactly the kind of access fda_citations gives an agent. Each links to the full case and the policy that stops it:
Other read tools across the catalogue. The same approach applies to each: allow, with a rate cap to control cost.
Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in openFDA API). Filter by company name, FEI number, CFR number (e.g., '21 CFR 211.68' for a specific section, or '21 CFR 211' for all cGMP violations), or keyword in citation descriptions. Returns the cited regulation, short and long descriptions of the finding, and inspection dates. Related: fda_inspections (inspection classification and dates by FEI), fda_compliance_actions (warning letters that may reference these citations).. It is categorised as a Read tool in the FDA Data MCP MCP Server, which means it retrieves data without modifying state.
Register the FDA Data MCP server in PolicyLayer and add a rule for fda_citations: allow, deny, rate-limit, or require approval. Point your MCP client at the PolicyLayer proxy URL and the rule is enforced on every call, before it reaches FDA Data MCP. Nothing to install.
fda_citations is a Read tool with low risk. Read-only tools are generally safe to allow by default.
Yes. Add a rate_limit block to the fda_citations rule in your PolicyLayer policy. For example, setting max: 10 and window: 60 limits the tool to 10 calls per minute. Rate limits are tracked per agent session and reset automatically.
Set action: deny in the PolicyLayer policy for fda_citations. The AI agent will receive a policy violation error and cannot call the tool. You can also include a reason field to explain why the tool is blocked.
fda_citations is provided by the FDA Data MCP server (https://www.regdatalab.com/mcp). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.
Deterministic rules across all 48 FDA Data MCP tools. Per-identity grants. Full audit log. Live in minutes. Nothing to install.
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