FDA Warning Letters & 483 Inspections API

FDA warning letters and Form 483 inspection observations — facilities, dates and findings.

Public regulatory/health data — not medical advice.

📊 Sample Output

type	date	publish_date	manufacturer	facility	state
form_483	2026-08-19	2026-09-22	STAQ Pharma of Ohio LLC	STAQ Pharma of Ohio LLC	Ohio
form_483	2026-08-18	2026-09-22	Carolina Infusion LLC	Carolina Infusion LLC	South Carolina
form_483	2026-08-12	2026-09-22	IntegraDose Compounding Services LLC	IntegraDose Compounding Services LLC	Minnesota
form_483	2026-08-12	2026-09-22	OurPharma LLC	OurPharma LLC	Arkansas
form_483	2026-07-31	2026-09-10	CD Pharmacy LLC dba Red Rock Pharmacy	CD Pharmacy LLC dba Red Rock Pharmacy	Utah
form_483	2026-07-28	2026-09-10	Apollo Care LLC	Apollo Care LLC	Montana

Real rows from run lfz0VkanGq5gP61JB on build 0.0.3 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.

⚙️ Sample inputs

This is the Store example input — the same input Apify's automated check runs — so it is proven to return rows on the current build. Paste it into the input form, or send it through the API, CLI or a schedule:

{
  "product_type": "any",
  "days_back": 180,
  "severity_filter": "both",
  "max_records": 50
}

🔧 Input reference

Field	Type	Default	What it does
manufacturer_name	string	""	Restrict results to compliance actions whose Company Name contains this substring (case-insensitive, legal suffixes like Inc./LLC/Ltd./Corp./GmbH/SRL stripped before matching). Le…
product_type	string (drug, device, food, biologic, any)	"any"	Filter to a specific FDA product category. The category is inferred from the Issuing Office (Warning Letters) or Establishment Type (Form 483s). drug=CDER, device=CDRH, food…
days_back	integer	180	How far back to scan. FDA Warning Letters typically have a 30-90 day lag between issue date and posting date. 180 days is the default for ongoing monitoring; 365 for quarterly com…
severity_filter	string (warning_letter_only, 483_only, both)	"both"	Restrict to one or both source feeds. warning_letter_only=public Warning Letters only (CDER/CDRH/CBER/Foods enforcement, ~1,000 letters available). 483_only=Form 483 inspectio…
max_records	integer	50	Hard cap on records pushed to the dataset (and metered for the per-action billing event). Records are returned newest-first by issue/inspection date, so a low cap returns the most…

🧾 JSON sample record

One real record from run lfz0VkanGq5gP61JB (emails/phones masked, long text shortened):

{
  "type": "form_483",
  "date": "2026-08-19",
  "publish_date": "2026-09-22",
  "manufacturer": "STAQ Pharma of Ohio LLC",
  "facility": "STAQ Pharma of Ohio LLC",
  "city": null,
  "state": "Ohio",
  "country": "USA",
  "fei_number": "3025336457",
  "product_type": "any",
  "establishment_type": "Outsourcing Facility",
  "record_type": 483,
  "observation_count": null,
  "severity": "recurring",
  "citation_summary": "Form 483 — Outsourcing Facility inspection",
  "full_text_url": "https://www.fda.gov/about-fda/office-regulatory-affairs/ora-foia-electronic-reading-room",
  "facility_severity_score": {
    "score": 2,
    "label": "recurring",
    "prior_warning_letters": 0,
    "prior_form_483s": 2
  },
  "source": "FDA OII FOIA Electronic Reading Room (Form 483 index)"
}

Fields that are always null in this version — and why

Field	Status
observation_count	Always null. FDA publishes Form 483 observation counts only inside the 483 PDF, which this actor does not parse.
city	Always null in the current feed; the company name, state and the letter/inspection link are delivered.

Each row is one FDA compliance action with its own source link. Where a 483 and a warning letter are shown together, the join is by FDA establishment identifier (FEI); heuristic severity is labelled as such.

💰 Pricing

Event	Price (USD)	When it is charged
Actor Start (apify-actor-start)	$0.005	Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event).
Compliance action (compliance-action)	$0.1	Per FDA Warning Letter or 483 inspection observation record

Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.1 = $10.00 plus the start fee.

🔗 Related Actors

More from the NexGenData Healthcare & FDA family:

• FDA Pharma Pipeline Tracker — Milestone Data API
• FDA Purple Book — Biologics & Biosimilars API
• FDA Recall Monitor — Drug & Device Safety Alerts
• Medical Device Records — FDA 510(k) & PMA API
• Medicare Provider Records — CMS Doctor Data API
• NPI Healthcare Provider Leads — Doctors & Practices API

15 more in this family on the NexGenData Store page.

⏰ Run this as a monitoring subscription (recommended)

Regulatory data is monitoring data. Schedule a weekly sweep (0 8 * * 1) and catch new records as they post — an always-on official-records feed.

📊 What you get

Clean JSON, one record per record (full output has 21 fields):

• type — Type
• date — Date
• posted_date — Posted date
• manufacturer — Manufacturer
• facility — Facility
• city — City
• state — State
• country — Country
• fei_number — Fei number
• product_type — Product type

Pricing: $0.1 per record (Pay-Per-Event) — about 10 per $1. Actor start fee $0.005 per run. Live prices are in the Pricing table below.

🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.

Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

🔗 Related regulatory actors

FDA & public-health records family:

OpenFDA Drug · Drug Approvals · Drug Shortages · Purple Book · Pharma Pipeline · Adverse Events · Medical Devices

Product-safety recalls: NHTSA Recalls · NHTSA Defects · NHTSA Safety · CPSC Recalls

Agent front door — Healthcare & FDA MCP: Healthcare & FDA MCP

This actor is currently private — treated and ready for review.

Public official records and enforcement data, assembled for research and monitoring.