Regulatory intelligence, grounded in the CFR

Smart-FDA is an AI-powered compliance platform for drugs, biologics, and medical devices. It tracks FDA citations, compares them to your company profile, and gives each stakeholder a prioritized list of where to act first.

Predict risk early

Generative AI analyzes current and historical 483s, recalls, and warning letters against your company profile to assess risk areas and overall exposure.

Grounded in the CFR

Every insight ties back to the Code of Federal Regulations sections that govern your products.

Prioritized for each role

Findings are ranked by importance and tailored to each stakeholder, so teams focus on the highest risks first.
Top risk areas for your site
Drug and biologic manufacturer, ranked by risk score
Top 6 of 10
  1. 1
    Laboratory controls92
    21 CFR 211.160
  2. 2
    Production and process controls85
    21 CFR 211.100
  3. 3
    Investigations of discrepancies78
    21 CFR 211.192
  4. 4
    Equipment cleaning and maintenance64
    21 CFR 211.67
  5. 5
    Quality control unit responsibilities57
    21 CFR 211.22
  6. 6
    Records and reports49
    21 CFR 211.180
Scores reflect your profile, questionnaire answers, and What If weights

Illustrative example

How it works

From your company profile to a ranked, tracked list of what to fix before the next inspection.

  1. Build your profile

    Tell Smart-FDA what you make, where, and under which CFR parts, so every insight fits your operation.

  2. Answer the questionnaire

    Work through a proprietary questionnaire where every question is tied to the CFR sections FDA cites.

  3. Run the algorithm

    Weight the factors that matter to you and see your top risk compliance areas, ranked.

  4. Act and track

    Turn findings into tracked projects, with the trigger and progress of each action in one place.

  5. Monitor and report

    Watch new 483s, recalls, and inspections daily, and report trends to leadership.

Modules for every part of inspection readiness

Monitor what FDA is doing, assess what it means for you, and act on it in one platform.

High priority

The latest 483s, observations, warning letters, EIRs, and inspections, summarized, with each record one click away.

Dashboard

Top risks by quality system, area, and CFR section, industry trends, and a Pareto of your site’s top 10 risk areas.

My daily view

Quick searches of 483s, recalls, and inspections by company, investigator, or region, with 483s downloadable as originals or annotated with quality system, area, and CFR section.

Questionnaire

A proprietary, CFR-linked questionnaire that shows how often each section is cited. Add your own questions or import them from Excel.

Project tracking

Follow up on actions from the questionnaire, an algorithm run, or any other trigger, without leaving Smart-FDA.

What if

A configurable risk projection algorithm. Change the weights, run it again, and see the impact on your top risks.

Reports

Dozens of ready-made reports on 483s, recalls, keywords, investigators, statistics, and trends.

Plain-language search

Ask about 483 trends, regulations, or observation categories in everyday language, then export the results to Excel.

Test your assumptions with What If

The most important part of risk projection is deciding what matters. What If puts a configurable algorithm in your hands so your projection reflects your supply chain, products, and priorities.

Weight what matters

Give more weight to 483s cited in a particular country, to more recent observations, and more.

Run it on your answers

Once the questionnaire is complete, run the algorithm to see your top risk compliance areas.

Change it and compare

Adjust the parameters, run again, and see how the ranking moves.
What If parameters
Risk projection, biologics profile
  • Recent 483sHigher weight
  • RegionEmphasize India
  • Warning lettersWeighted x1.5
  • Product typeBiologics
Run algorithm
With India emphasized, investigations of discrepancies moves from 3rd to 1st.

Illustrative example

Assess your site, and your suppliers

One questionnaire structure for your own operation and for the third parties you depend on.

CFR-linked questionnaire

A proprietary self-assessment where every question connects to the CFR sections FDA actually cites.
  • Pre-defined questions, each connected to the CFR sections FDA cites
  • The number of times each CFR section has been cited, shown beside the question
  • Your own questions, added directly or imported from Excel in the Smart-FDA structure
  • Answers feed straight into the risk projection algorithm

Third-party vendor watch

Know when a supplier or contract partner draws FDA attention, before it becomes your problem.
  • Third-party questionnaires for suppliers and contract partners
  • Supplier questionnaires built on the same CFR-linked structure as your own
  • Notifications when a vendor receives a 483, an inspection, a recall, and more

A deep, continuously refreshed enforcement database

Smart-FDA is cloud-based and integrated with FDA FOIA data. The team monitors FDA activity and refreshes the database continuously, across drugs, biologics, and medical devices.

InspectionsForm 483sWarning lettersRecallsEIRsFDA CFRsFOIA data

55,000+

FDA inspections analyzed

15,000+

Form 483 observations

16,000+

Recalls, warning letters, and EIRs

<1 week

To go live

Solutions Overview

Smart-FDA at a glance

Download our two-page guide to Smart-FDA risk projection, modules, and the enforcement data behind them.

Complete the form to download.

Get ahead of your next inspection.

Tell us what you make and where. We will show you the
risk areas FDA is most likely to cite at your site.

Schedule a demo
Contact sales