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FDA Compliance Monitor — Recalls, CRLs & Safety Signals

Try for free

Monitor the official openFDA API — recalls, FAERS adverse events, drug approvals, device 510(k)/PMA decisions and Complete Response Letters. Company watchlists across every FDA dataset.

Pricing

$1.00 / 1,000 result rows

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William Billings

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3 days ago

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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.

Example output

{
  "recordType": "recall",
  "productArea": "drug",
  "recallNumber": "D-1381-2020",
  "eventId": "85906",
  "status": "Terminated",
  "classification": "Class III",
  "recallingFirm": "Biogen MA Inc.",
  "productType": "Drugs",
  "productDescription": "Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02",
  "reasonForRecall": "cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.",
  "productQuantity": "3,922 bottles",
  "codeInfo": "Lot # SH0274, Exp 2/2022",
  "reportDate": "2020-07-15",
  "recallInitiationDate": "2020-06-23"
}

FAQ

Does FDA Compliance Monitor need a login or API key? No — every row comes from public endpoints. Provide a proxy only if your network is heavily rate-limited.

How do I monitor on a schedule? Attach the actor to an Apify Schedule (daily/weekly) and use the watch/monitor mode if present — each run emits a fresh, diff-able dataset.

What does each row contain? See the output fields table above; every row carries a scrapedAt timestamp so datasets can be deduped across runs.

Is it legal to scrape this data? The actor only accesses publicly available data — the same pages/APIs a browser sees. Scraping public data for research, monitoring, and analysis is common practice, but platform Terms of Service and the rules in your jurisdiction still apply to how you use it. Consult legal counsel for your specific case.

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