# RegDataLab
> Manufacturing-first FDA intelligence for AI agents. Start with one company-level summary, then drill into inspections, warning letters, OII records, import risk, facilities, approvals, recalls, shortages, and specialty datasets.

## Authentication
- Header auth (preferred): `Authorization: Bearer fda_...`
- Local stdio wrapper for clients without native HTTP: `FDA_DATA_API_KEY=fda_... npx -y fda-data-mcp`
- Streamable HTTP endpoint: `https://www.regdatalab.com/mcp`
- Root discovery file: `https://www.regdatalab.com/.well-known/mcp.json`
- Default free-tier limits: `300` credits/month, `60` requests/minute

## Recommended workflow
- First tool for company-level manufacturing and compliance work: `fda_manufacturing_risk_summary`
- Second step when you already know the FEI: `fda_facility_dossier`
- Second step when you want one dated event stream: `fda_company_compliance_timeline`
- Good first prompts:
  - `Give me a manufacturing risk summary for Pfizer.`
  - `Summarize recent warning letters, inspections, and import alerts for Moderna.`
  - `Show manufacturing risk summary plus recent OII records for Thermo Fisher.`
- Matching tips:
  - Start with the most canonical company name you know
  - Narrow to a subsidiary, FEI, country, or facility when broad matching is noisy
  - Avoid many heavy tool calls in parallel until you know the exact entity you need
- Credit tips:
  - Credits are consumed per successful tool call
  - Credit exhaustion returns `402`
  - Rate limiting returns `429`

## Setup

### Claude Desktop / Cowork
- Use the published `fda-data-mcp` stdio wrapper (equivalent to `FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp`)
- Add it to `claude_desktop_config.json` and restart Claude Desktop
- Cowork uses the MCPs you already connected in Claude Desktop, so no extra setup is needed in Cowork
- See the JSON config below

### Claude Desktop / Cowork config
Use the published wrapper in `claude_desktop_config.json`:
```json
{
  "mcpServers": {
    "fda-data": {
      "command": "npx",
      "args": [
        "-y",
        "fda-data-mcp"
      ],
      "env": {
        "FDA_DATA_API_KEY": "YOUR_API_KEY"
      }
    }
  }
}
```

### Claude Code
```bash
claude mcp add fda-data https://www.regdatalab.com/mcp \
  --transport http \
  --header "Authorization: Bearer YOUR_API_KEY"
```

### Cursor / Windsurf
Use the same published `fda-data-mcp` wrapper pattern as Claude Desktop JSON config.

### OpenAI API
Use the Responses API remote MCP tool type with:
- `server_url`: `https://www.regdatalab.com/mcp`
- `Authorization: Bearer YOUR_API_KEY`

## Tools

### Start Here
- `fda_manufacturing_risk_summary`: Best first tool for a company-level manufacturing and compliance summary across inspections, warning letters, OII records, import risk, debarments, facilities, and recalls.

### Manufacturing & Compliance
- `fda_inspections`: Search FDA inspections with NAI, VAI, and OAI outcomes by company, FEI, date, and geography.
- `fda_citations`: Search inspection citations and CFR findings tied to facilities and companies.
- `fda_compliance_actions`: Search warning letters, seizures, and injunctions from FDA compliance dashboards.
- `fda_search_warning_letters`: Search FDA warning letters with text, excerpts, dates, and issuing office context.
- `fda_search_oii_records`: Search OII reading-room records, including machine-readable inspection and compliance documents.
- `fda_search_debarments`: Search FDA debarment records and integrity-related exclusions.
- `fda_search_import_alerts`: Search import alerts, red-list and green-list placements, and linked firms.
- `fda_search_opdp_untitled_letters`: Search OPDP untitled letters for pharma promotional and commercial compliance issues.
- `fda_bpdr_summary`: Review BPDR annual summary data for biologics manufacturing and quality signal context.
- `fda_device_supply_status`: Check device supply disruption and shortage signals for medtech manufacturing monitoring.
- `fda_inspection_observation_summary`: Review annual inspection observation summary trends and common citation patterns.
- `fda_import_refusals`: Search import refusal records by company, FEI, country, category, and date.
- `fda_ires_enforcement`: Search iRES enforcement and recall records from FDA internet Recall Enterprise System data.

### Company & Facility Intelligence
- `fda_lookup_company`: Quick company view across facilities, enforcement history, and alias resolution.
- `fda_search_facilities`: Search FDA facilities by company, location, and operating context.
- `fda_search_family_facilities`: Search FDA facilities across a parent company and explicitly linked subsidiaries.
- `fda_get_facility`: Open a detailed facility record by FEI, including linked enforcement context.
- `fda_facility_dossier`: Build a compliance-first FEI dossier with inspections, citations, warning letters, import-risk signals, recalls, and freshness.
- `fda_facility_products`: List products and classifications linked to a facility.
- `fda_resolve_company`: Resolve a company to its normalized aliases and canonical record.
- `fda_save_aliases`: Save alias mappings for a parent company when you need cleaner future matching.
- `fda_link_subsidiaries`: Explicitly link child companies under a parent for family-aware rollups.
- `fda_suggest_subsidiaries`: Suggest FDA-first, evidence-backed subsidiaries and related company records using FDA data first and EDGAR/GLEIF as supplemental corporate hierarchy hints.
- `fda_company_full`: Pull a broader company profile across facilities, recalls, approvals, and drug/device coverage.
- `fda_company_compliance_timeline`: Build a reverse-chronological compliance timeline across inspections, warning letters, import risk, debarments, and recalls.

### Products, Approvals & Labels
- `fda_search_510k`: Search FDA 510(k) clearances by company, product code, and decision details.
- `fda_search_pma`: Search FDA PMA approvals by company, product code, and decision window.
- `fda_search_drugs`: Search Drugs@FDA applications, brand names, and submission status.
- `fda_search_ndc`: Search the NDC directory by labeler, brand, or application number.
- `fda_search_nsde`: Search National Standard Drug Element records by name, package NDC, and application number.
- `fda_search_by_product`: Search across drug and device product-oriented datasets by product name.
- `fda_device_class`: Look up device classification details by product code.
- `fda_product_code_lookup`: Cross-reference a product code across classification, 510(k), and PMA data.
- `fda_clinical_result_letters`: Search Complete Response Letters and related FDA transparency records.
- `fda_drug_labels`: Search SPL drug labels, sections, manufacturers, and application references.
- `fda_device_udi`: Search the FDA UDI dataset for device identifiers, companies, and product codes.
- `fda_device_udi_lookup`: Look up GUDID-style UDI records directly.

### Recalls, Safety & Specialty
- `fda_search_enforcement`: Search recall and enforcement actions across drug, device, and food records.
- `fda_search_recall_text`: Search recall reason text and product descriptions across enforcement records.
- `fda_recall_facility_trace`: Trace recalls back to likely facilities and manufacturing entities.
- `fda_drug_shortages`: Search active and resolved FDA drug shortages.
- `fda_device_recalls`: Search device recall records with firm, product code, and status filters.
- `fda_consumer_events`: Search food and cosmetic adverse events.
- `fda_vet_events`: Search veterinary adverse event records.
- `fda_tobacco_problems`: Search tobacco product problem reports and health issues.
- `fda_substance_lookup`: Look up FDA substance and UNII data by code or name.
- `fda_search_aphis`: Search APHIS veterinary biologics establishments and related references.

## Dataset Coverage

### Manufacturing & Compliance
- FDA Inspections [tool: `fda_inspections`]
- FDA Citations [tool: `fda_citations`]
- Compliance Actions [tool: `fda_compliance_actions`]
- FDA Warning Letters [tool: `fda_search_warning_letters`]
- OII Reading Room [tool: `fda_search_oii_records`]
- Import Refusals [tool: `fda_import_refusals`]
- Import Alerts [tool: `fda_search_import_alerts`]
- FDA Debarments [tool: `fda_search_debarments`]
- iRES Enforcement [tool: `fda_ires_enforcement`]
- Inspection Observation Summary [tool: `fda_inspection_observation_summary`]
- OPDP Untitled Letters [tool: `fda_search_opdp_untitled_letters`]
- BPDR Annual Summaries [tool: `fda_bpdr_summary`]
- Device Supply Status [tool: `fda_device_supply_status`]

### Company & Facility Intelligence
- DECRS [tool: `fda_search_facilities`]
- Device Registration & Listing [tool: `fda_search_facilities`]

### Products, Approvals & Labels
- Drugs@FDA [tool: `fda_search_drugs`]
- NDC Directory [tool: `fda_search_ndc`]
- Drug Labels (SPL) [tool: `fda_drug_labels`]
- 510(k) Clearances [tool: `fda_search_510k`]
- PMA Approvals [tool: `fda_search_pma`]
- Device Classification [tool: `fda_device_class`]
- Device UDI [tool: `fda_device_udi`]
- NSDE [tool: `fda_search_nsde`]
- Clinical Result Letters [tool: `fda_clinical_result_letters`]
- COVID-19 Serology [tool: `fda_search_by_product`]
- Historical Documents [tool: `fda_search_by_product`]

### Recalls, Shortages & Safety
- Drug Enforcement Recalls [tool: `fda_search_enforcement`]
- Device Enforcement Recalls [tool: `fda_search_enforcement`]
- Food Enforcement Recalls [tool: `fda_search_enforcement`]
- Device Recalls [tool: `fda_device_recalls`]
- Drug Shortages [tool: `fda_drug_shortages`]
- Food Adverse Events [tool: `fda_consumer_events`]
- Cosmetic Adverse Events [tool: `fda_consumer_events`]
- Tobacco Problem Reports [tool: `fda_tobacco_problems`]

### Veterinary & Specialty
- Veterinary Adverse Events [tool: `fda_vet_events`]
- APHIS Veterinary Biologics [tool: `fda_search_aphis`]
- Substance UNII [tool: `fda_substance_lookup`]

## References
- Human-readable docs: https://www.regdatalab.com/docs
- Connection guide: https://www.regdatalab.com/connect.md
- Dataset guide: https://www.regdatalab.com/datasets
- Tool discovery JSON: https://www.regdatalab.com/api