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Now tracking 1M+ FDA records daily

Turn FDA Data Into
Competitive Advantage

The only platform that unifies FDA enforcement signals and product intelligence—then converts insights into audit-ready 483 responses, CAPAs, inspection-readiness assessments, and executive reports in minutes.

500+ quality leaders trust PIOL Radar
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Claude Opus 4.5Enterprise AI
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Built for Compliance Teams

Trusted by Quality Leaders

Secure Infrastructure

Built on Supabase with row-level security, encrypted connections, and secure authentication. Your data stays protected.

Regulatory Expertise

Built by compliance professionals who understand 21 CFR Part 11, 483 response requirements, and FDA inspection processes.

AI You Can Trust

Every AI-generated document includes traceable FDA citations. Review and edit before use—you stay in control.

Official FDA data from:

DDAPI
OpenFDA
iRES
PCB

Platform Features

Everything You Need for FDA Compliance

From AI-powered document generation to real-time FDA data sync, PIOL Radar gives quality teams the tools to stay ahead of enforcement.

300K+

FDA Facilities

4

Data Sources

8

AI Tools

Daily

Data Sync

AI-Powered Tools

8 specialized tools powered by Claude Opus 4.5

Generate compliance documents in minutes, not days. Each tool is trained on FDA regulations and real enforcement patterns.

CAPA Generator

AI-generated corrective action plans from 483 observations

SOP/WI Generator

Standard operating procedures and work instructions

483 Response Letters

Professional FDA response letters with timelines

White Papers

Compliance reports with automatic FDA citations

AI Reports

Custom analytical reports on any compliance topic

Peer Benchmarking

Compare your compliance posture against competitors

Inspection Readiness

AI-scored inspection preparedness with gap analysis

AI Assistant

Natural language queries across all FDA data

Supplier Evaluation

Know Your Supply Chain Risk

Don't wait for an FDA inspection to discover supplier problems. Monitor your entire supply chain in real-time and get alerts before issues become your issues.

Instant Alerts

New 483s, recalls, warnings

Risk Scoring

Aggregate group metrics

Trend Analysis

Compare over time

Due Diligence

Export audit reports

Available on Standard (5 groups) and Professional (25 groups) plans

Supplier Groups
4 groups · 41 suppliers

Raw Materials

12 suppliers

85

Risk Score

+3

Contract Manufacturing

8 suppliers

68

Risk Score

-2

Packaging & Labeling

15 suppliers

91

Risk Score

+5

Logistics Partners

6 suppliers

42

Risk Score

-8
Last updated: Today, 9:42 AM
Monitoring active

Built For Your Role

Solutions for Every Quality Leader

Whether you're setting strategy or executing daily compliance, PIOL Radar adapts to your needs.

Chief Quality Officer

Strategic Oversight & Board Reporting

The Challenge

Spending weeks compiling board reports from scattered data sources. No real-time visibility into portfolio risk. Difficult to benchmark against industry peers or demonstrate ROI on quality investments.

The Solution

Get executive dashboards that update automatically with AI-generated board summaries. See portfolio risk at a glance, benchmark your facilities against competitors, and demonstrate compliance posture to stakeholders with professional reports.

Key Features for Chief Quality Officers

  • Portfolio risk scoring across all facilities
  • Peer benchmarking vs. industry competitors
  • AI-generated executive summaries
  • One-click board presentation exports
  • Trend analysis over 3 years of data
  • Supplier group risk aggregation

How It Works

From Data to Decisions in 4 Steps

Get started in minutes. No complex setup required.

1

Access FDA Data Instantly

All FDA enforcement data is already synced and ready. Browse facilities, 483s, recalls, and more from day one.

No setup required
2

Use AI-Powered Tools

Generate CAPAs, SOPs, response letters, and white papers with Claude Opus 4.5. Citations included automatically.

8 specialized AI tools
3

Track What Matters

Add your facilities and suppliers to monitor. Get alerts when FDA takes action on companies you care about.

Custom watchlists
4

Export & Report

Download professional reports in PDF, Word, or Excel. Share insights with your team and stakeholders.

Board-ready exports

Simple, Transparent Pricing

Choose the plan that fits your needs. All paid plans include a 7-day free trial with limited access.

-10%
-20%
Try the platform

Explorer

Explore FDA data with AI Assistant

$79/mo
50K tokens/mo
  • 180 days FDA data history
  • 1 facility tracking
  • All exports (PDF)
  • 50K AI tokens/month
  • AI Assistant
  • Supplier Evaluation
  • CAPA Generator
  • SOP/WI Generator
  • 483 Response Letters
  • Inspection Readiness
  • Peer Benchmarking
  • Scenario Planner
  • AI Reports
  • White Papers
Start Free Trial

7-day free trial included

Most Popular

Standard

Full AI access for quality professionals

$249/mo
250K tokens/mo
  • 1 year FDA data history
  • 5 facilities tracking
  • All exports (PDF, DOCX)
  • 250K AI tokens/month
  • AI Assistant
  • Supplier Evaluation
  • CAPA Generator
  • SOP/WI Generator
  • 483 Response Letters
  • Inspection Readiness
  • Peer Benchmarking
  • Scenario Planner
  • AI Reports
  • White Papers
Start Free Trial

7-day free trial included

Best Value

Professional

Advanced analytics for power users

$529/mo
500K tokens/mo
  • 5 years FDA data history
  • 25 facilities tracking
  • All exports (PDF, DOCX, Excel)
  • 500K AI tokens/month
  • AI Assistant
  • Supplier Evaluation
  • CAPA Generator
  • SOP/WI Generator
  • 483 Response Letters
  • Inspection Readiness
  • Peer Benchmarking
  • Scenario Planner
  • AI Reports
  • White Papers
Start Free Trial

7-day free trial included

Custom solution

Enterprise

For large organizations with custom needs

Custom
Unlimited tokens

May include:

  • Custom data history limits
  • Unlimited facilities & supplier groups
  • Unlimited AI tokens
  • Dedicated account manager
  • API access & SSO integration
  • Custom onboarding & training

Contact us to discuss your specific requirements and receive a custom quote.

Contact Sales

Custom onboarding included

7-Day Free Trial

Explore before you commit

Token Top-ups

Buy more when you need them

Cancel Anytime

No long-term contracts

7-Day Free Trial on All Plans

Try PIOL Radar risk-free. Cancel anytime during the trial and you won't be charged.

30 DaysFDA Data History
All FDA DataIncluding Citations
No AI TokensUnlocks After Trial
PDF ExportsWatermarked

Payment method required. One free trial per account. Cancel anytime before the trial ends.

FAQ

Everything You Need to Know

Quick answers to common questions about PIOL Radar.

4 FDA sources

Synced daily

8 AI tools

Claude Opus 4.5

Secure

Row-level security

7-day trial

Cancel anytime

FDA Data & Sources

4 official databases, daily sync

We integrate with 4 official FDA data sources: DDAPI (Drug Database API), OpenFDA, iRES (Import Refusal Entry System), and PCB (Problem Code Database). This gives you comprehensive coverage of facilities, inspections, 483s, warning letters, recalls, adverse events, compliance actions, and import refusals.
4 data sources
Our system syncs with FDA databases daily to ensure you always have the most current information. Critical enforcement actions like warning letters and Class I recalls are typically available within 24 hours of FDA publication.
Daily updates
Data history depends on your plan: Free trial includes 30 days, Explorer includes 180 days, Standard includes 1 year, and Professional includes 5 years. All plans include access to the same FDA data types—only the date range differs.
Up to 5 years
Beyond enforcement data, we include FDA product registrations: device classifications, 510(k) clearances, PMA approvals, device registrations, drug NDC directory, and drug application approvals (NDA, ANDA, BLA). This helps you understand the regulatory landscape for any product category.
Full product data
Yes! All plans include access to CFR Citations, which maps 21 CFR regulation references to violations and patterns across enforcement actions. You can search by specific CFR section to see which facilities have been cited and understand common compliance gaps.
CFR mapping

Still have questions?

Our team is ready to help with your specific requirements, custom integrations, or enterprise needs.

Contact Sales