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.
37
Datasets
44
MCP Tools
5
Categories
Manufacturing-first
Positioning
Older FDA inventory pages tend to read like raw lists. This one is organized for how people actually work: manufacturing and compliance first, then company and facility context, then products, recalls, shortages, and specialty data.
This is the highest-value slice for pharma, biotech, and medtech manufacturing work: inspections, citations, warning letters, OII records, import risk, debarments, and related compliance evidence.
Inspection history with NAI, VAI, and OAI classifications.
“Find recent OAI inspections for a company”
fda_inspectionsDetailed CFR citations and observation text linked to inspections.
“Search 21 CFR 211 citations for a firm”
fda_citationsSerious enforcement outcomes from FDA dashboard sources.
“Find recent warning letters tied to a company”
fda_compliance_actionsLetter metadata plus body text and excerpts when available.
“Search warning letters for aseptic processing issues”
fda_search_warning_lettersOII reading-room records and machine-readable document text when FDA publishes it.
“Find recent OII records for a manufacturer”
fda_search_oii_recordsRefused products by company, FEI, country, category, and date.
“Search import refusals from India for a supplier”
fda_import_refusalsImport alert notices and firm-level red-list / green-list placement records.
“Check whether a manufacturer is on an import alert”
fda_search_import_alertsDebarment records relevant to pharma and device integrity review.
“Find debarment records tied to a company name”
fda_search_debarmentsInternet Recall Enterprise System records beyond the older openFDA recall framing.
“Search iRES recall activity for a firm”
fda_ires_enforcementOfficial FDA annual summaries of common inspection observation patterns.
“See which citation themes show up most often in drugs”
fda_inspection_observation_summaryCommercial and promotional compliance signal for drug makers.
“Review OPDP letters for a pharma company”
fda_search_opdp_untitled_lettersBiologics manufacturing signal from annual BPDR summary releases.
“Check BPDR themes relevant to biologics operations”
fda_bpdr_summaryMedtech shortage and discontinuance signal published by FDA.
“Check device supply status for a medtech manufacturer”
fda_device_supply_statusThese datasets become more useful once you already know the company, product, facility, or compliance question you want to explore.
Current drug establishment registration site records.
“Find API manufacturing facilities for a company”
fda_search_facilitiesDevice registration and listing data linked to facilities and firms.
“Find device facilities in California”
fda_search_facilitiesThese datasets become more useful once you already know the company, product, facility, or compliance question you want to explore.
Drug applications, sponsors, statuses, and approval-related records.
“Find approved applications for a company”
fda_search_drugsNational Drug Code directory with labeler and product detail.
“Look up products for a labeler”
fda_search_ndcStructured Product Labeling content, sections, and manufacturers.
“Read boxed warnings for a drug”
fda_drug_labelsSearch 510(k) records by company, product code, and decision window.
“Find recent 510(k) decisions for Medtronic”
fda_search_510kPMA application and approval data for higher-risk devices.
“Search PMA approvals for cardiac devices”
fda_search_pmaClassification details and regulatory framing for device product codes.
“Check the class for a device product code”
fda_device_classDevice identifier, brand, and company records from FDA UDI sources.
“Look up UDI entries for Abbott devices”
fda_device_udiNational Standard Drug Element records for products and packages.
“Search NSDE entries for a drug name”
fda_search_nsdeComplete Response Letters and related FDA transparency records.
“Search CRLs for a sponsor”
fda_clinical_result_lettersCOVID-19 serology test records and supporting product detail.
“Search COVID-19 serology records by product”
fda_search_by_productHistorical FDA documents and product-related archive material.
“Search historical FDA records for a company”
fda_search_by_productThese datasets become more useful once you already know the company, product, facility, or compliance question you want to explore.
Drug recall actions and classification history.
“Find Class I drug recalls from 2025”
fda_search_enforcementDevice enforcement recall actions and classification history.
“Search device enforcement actions by firm”
fda_search_enforcementFood-related enforcement recall records in the same search surface.
“Find recent food enforcement recalls”
fda_search_enforcementDevice recall records focused on firm, product code, and status.
“Search infusion pump recalls”
fda_device_recallsFDA drug shortage data with status and availability context.
“Find active oncology drug shortages”
fda_drug_shortagesFood-related adverse event reports from consumer reporting datasets.
“Search allergic reaction reports in food events”
fda_consumer_eventsCosmetic adverse event reports in the same consumer event surface.
“Find cosmetic adverse events from 2025”
fda_consumer_eventsProblem and health issue reporting for tobacco products.
“Search tobacco reports for e-cigarettes”
fda_tobacco_problemsThese datasets become more useful once you already know the company, product, facility, or compliance question you want to explore.
Veterinary adverse event records by species, drug, and reaction.
“Search reports for canine heartworm drugs”
fda_vet_eventsAPHIS veterinary biologics establishment records.
“Search APHIS veterinary biologics establishments”
fda_search_aphisUNII substance and ingredient reference data.
“Look up the UNII for acetaminophen”
fda_substance_lookupNew accounts start with 300 free credits and 60 requests per minute. The fastest path is to start with a manufacturing summary, then drill into the exact dataset you need.