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Start with manufacturing and compliance sources when you need company risk context, then branch into facilities, approvals, labels, recalls, shortages, and specialty datasets as the question narrows. Each dataset is normalized with provenance metadata and reachable through one MCP endpoint.
37
FDA datasets
48
MCP tools
5
Coverage areas
Manufacturing-first
Positioning
The highest-value slice for pharma, biotech, and medtech manufacturing work: inspections, citations, warning letters, OII records, import risk, debarments, and related compliance evidence.
| Dataset | Query it for | Coverage | Primary tool |
|---|---|---|---|
| FDA Inspections | Inspection history with NAI, VAI, and OAI classifications. “Find recent OAI inspections for a company” | inspection outcomes | fda_inspections |
| FDA Citations | Detailed CFR citations and observation text linked to inspections. “Search 21 CFR 211 citations for a firm” | 483-style findings | fda_citations |
| Compliance Actions | Serious enforcement outcomes from FDA dashboard sources. “Find recent warning letters tied to a company” | warning letters, seizures, injunctions | fda_compliance_actions |
| FDA Warning Letters | Letter metadata plus body text and excerpts when available. “Search warning letters for aseptic processing issues” | full-text letter archive | fda_search_warning_letters |
| OII Reading Room | OII reading-room records and machine-readable document text when FDA publishes it. “Find recent OII records for a manufacturer” | inspection and compliance documents | fda_search_oii_records |
| Import Refusals | Refused products by company, FEI, country, category, and date. “Search import refusals from India for a supplier” | border enforcement records | fda_import_refusals |
| Import Alerts | Import alert notices and firm-level red-list / green-list placement records. “Check whether a manufacturer is on an import alert” | alert lists and firm placements | fda_search_import_alerts |
| FDA Debarments | Debarment records relevant to pharma and device integrity review. “Find debarment records tied to a company name” | integrity and exclusion records | fda_search_debarments |
| iRES Enforcement | Internet Recall Enterprise System records beyond the older openFDA recall framing. “Search iRES recall activity for a firm” | recall and enforcement feed | fda_ires_enforcement |
| Inspection Observation Summary | Official FDA annual summaries of common inspection observation patterns. “See which citation themes show up most often in drugs” | annual summary tables | fda_inspection_observation_summary |
| OPDP Untitled Letters | Commercial and promotional compliance signal for drug makers. “Review OPDP letters for a pharma company” | promotional compliance letters | fda_search_opdp_untitled_letters |
| BPDR Annual Summaries | Biologics manufacturing signal from annual BPDR summary releases. “Check BPDR themes relevant to biologics operations” | biologics deviation summaries | fda_bpdr_summary |
| Device Supply Status | Medtech shortage and discontinuance signal published by FDA. “Check device supply status for a medtech manufacturer” | supply disruption signals | fda_device_supply_status |
Reach for these once you already know the company, product, facility, or compliance question you want to explore.
| Dataset | Query it for | Coverage | Primary tool |
|---|---|---|---|
| DECRS | Current drug establishment registration site records. “Find API manufacturing facilities for a company” | drug establishment registration | fda_search_facilities |
| Device Registration & Listing | Device registration and listing data linked to facilities and firms. “Find device facilities in California” | device establishment records | fda_search_facilities |
Reach for these once you already know the company, product, facility, or compliance question you want to explore.
| Dataset | Query it for | Coverage | Primary tool |
|---|---|---|---|
| Drugs@FDA | Drug applications, sponsors, statuses, and approval-related records. “Find approved applications for a company” | drug applications and submissions | fda_search_drugs |
| NDC Directory | National Drug Code directory with labeler and product detail. “Look up products for a labeler” | drug product directory | fda_search_ndc |
| Drug Labels (SPL) | Structured Product Labeling content, sections, and manufacturers. “Read boxed warnings for a drug” | structured labeling text | fda_drug_labels |
| 510(k) Clearances | Search 510(k) records by company, product code, and decision window. “Find recent 510(k) decisions for Medtronic” | device premarket notifications | fda_search_510k |
| PMA Approvals | PMA application and approval data for higher-risk devices. “Search PMA approvals for cardiac devices” | high-risk device approvals | fda_search_pma |
| Device Classification | Classification details and regulatory framing for device product codes. “Check the class for a device product code” | product code and class mapping | fda_device_class |
| Device UDI | Device identifier, brand, and company records from FDA UDI sources. “Look up UDI entries for Abbott devices” | device identifier records | fda_device_udi |
| NSDE | National Standard Drug Element records for products and packages. “Search NSDE entries for a drug name” | drug establishment elements | fda_search_nsde |
| Clinical Result Letters | Complete Response Letters and related FDA transparency records. “Search CRLs for a sponsor” | FDA transparency letters | fda_clinical_result_letters |
| COVID-19 Serology | COVID-19 serology test records and supporting product detail. “Search COVID-19 serology records by product” | test and performance records | fda_search_by_product |
| Historical Documents | Historical FDA documents and product-related archive material. “Search historical FDA records for a company” | archival FDA records | fda_search_by_product |
Reach for these once you already know the company, product, facility, or compliance question you want to explore.
| Dataset | Query it for | Coverage | Primary tool |
|---|---|---|---|
| Drug Enforcement Recalls | Drug recall actions and classification history. “Find Class I drug recalls from 2025” | drug recall enforcement | fda_search_enforcement |
| Device Enforcement Recalls | Device enforcement recall actions and classification history. “Search device enforcement actions by firm” | device recall enforcement | fda_search_enforcement |
| Food Enforcement Recalls | Food-related enforcement recall records in the same search surface. “Find recent food enforcement recalls” | food recall enforcement | fda_search_enforcement |
| Device Recalls | Device recall records focused on firm, product code, and status. “Search infusion pump recalls” | device-specific recall feed | fda_device_recalls |
| Drug Shortages | FDA drug shortage data with status and availability context. “Find active oncology drug shortages” | active and resolved shortage records | fda_drug_shortages |
| Food Adverse Events | Food-related adverse event reports from consumer reporting datasets. “Search allergic reaction reports in food events” | consumer safety reports | fda_consumer_events |
| Cosmetic Adverse Events | Cosmetic adverse event reports in the same consumer event surface. “Find cosmetic adverse events from 2025” | consumer safety reports | fda_consumer_events |
| Tobacco Problem Reports | Problem and health issue reporting for tobacco products. “Search tobacco reports for e-cigarettes” | tobacco problem records | fda_tobacco_problems |
Reach for these once you already know the company, product, facility, or compliance question you want to explore.
| Dataset | Query it for | Coverage | Primary tool |
|---|---|---|---|
| Veterinary Adverse Events | Veterinary adverse event records by species, drug, and reaction. “Search reports for canine heartworm drugs” | animal drug safety reports | fda_vet_events |
| APHIS Veterinary Biologics | APHIS veterinary biologics establishment records. “Search APHIS veterinary biologics establishments” | establishment references | fda_search_aphis |
| Substance UNII | UNII substance and ingredient reference data. “Look up the UNII for acetaminophen” | ingredient and substance records | fda_substance_lookup |
New accounts start with 50 credits — verify your email to unlock 300 a month — at 60 requests per minute. Begin with a manufacturing summary, then drill into the exact dataset you need.