FDA Compliance Monitor

Monitor the FDA's own openFDA API for recalls, adverse events, drug approvals, device clearances, and Complete Response Letters — compliance intelligence for pharma, biotech, med-device, and regulatory affairs teams.

No API key required. No browser. Pure official FDA data.

Modes

Mode	What it returns	Data source
recalls	Drug, food, and device enforcement actions	openFDA enforcement
adverse	Drug adverse-event reports (FAERS)	openFDA drug/event
approvals	Drug approval records & submission history	Drugs@FDA
clearances	Device 510(k) clearances & PMA approvals	openFDA device
crl	Complete Response Letters — including full letter text	FDA transparency dataset (new 2025)
company	One firm's entire FDA footprint — recalls, CRLs, approvals, devices in one feed	all of the above

Example inputs

Watch a company across every FDA dataset:

{"mode": "company", "query": "medtronic", "dateAfter": "2025-09-01"}

New Class I drug recalls this month:

{"mode": "recalls", "productArea": "drugs", "classification": "Class I", "dateAfter": "2025-09-01"}

Serious adverse events for a drug (weekly monitor):

{"mode": "adverse", "query": "ozempic", "seriousOnly": true, "dateAfter": "2025-09-22"}

A competitor's Complete Response Letters:

{"mode": "crl", "query": "biogen"}

Latest device clearances:

{"mode": "clearances", "deviceType": "510k", "dateAfter": "2025-09-01"}

Monitoring pattern

Schedule this actor weekly with dateAfter = your last run date and a query or company watch — each run emits only what changed. Ideal for:

• Competitive intelligence — rival CRLs, recalls, and approvals as they publish
• Safety signals — adverse-event streams for your products or a competitor's
• Regulatory affairs — recall classifications and warning data by firm
• Investment research — CRLs and approval decisions before headlines

Fields (per record)

Every row carries recordType so mixed feeds stay readable: recall, adverse_event, drug_approval, device_510k, pma_approval, or complete_response_letter — plus dates, firm/applicant/sponsor, product details, classification, and the letter text excerpt for CRLs.

Notes & limitations

• All data comes from the official openFDA API — free, public, no key.
• openFDA search accepts a single filter clause per request; this actor applies additional filters client-side. adverse mode without a date range returns the oldest matching reports first (the API does not sort) — always pass dateAfter for monitoring.
• FDA datasets lag real-world events (recalls post within days; FAERS reports can lag weeks).
• CRL textExcerpt is truncated to 1,500 chars — fileName identifies the full PDF on FDA.gov.

Pricing

Pay-per-event: ~$1 per 1,000 records returned, billed on Apify's current pricing format. No per-run fee.