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Pharma Observatory a Scientist.com platform

Regulatory, quality, and supplier-risk teams

Check a firm's FDA enforcement history before you engage

Inspections, Form 483 observations, warning letters, recalls and import refusals attached to the firm, with firms that could not be matched shown as such.

Individual plan, $249/seat/mo. Card required.

The FDA enforcement page: filters by source, and a stacked bar chart of inspections, warning letters, recalls and import refusals per quarter with the Official Action Indicated rate as a line
The FDA enforcement page: inspections, warning letters, recalls, import refusals and debarments per quarter, with the Official Action Indicated rate. Captured from production data on 2026-10-10.

The problem today

FDA publishes inspections, 483s, warning letters, recalls and import refusals in separate databases, each with its own spelling of the firm name. Screening one supplier means searching all of them and deciding which entries are the same company. A missed name variant is a missed warning letter.

Why this beats what you do now

  • One search across FDA's records. Inspections, letters, recalls and import refusals for a firm appear together.
  • Name variants matched. Firm spellings are joined, and an item that could not be matched is marked.
  • Missing is labeled missing. Disclosure views show not disclosed as such and never as a no.
  • Bought on a card. The Individual plan is published at $249/seat/mo and starts with a 14-day trial.

What you can answer

Pages marked free open without an account. The rest open in the product, starting with a 14-day trial.

What has FDA recorded against a firm?

FDA Enforcement lists inspections and Form 483s, warning and untitled letters, recalls, import refusals and debarments from public US FDA data. Filter to a name to see every event attached to it.

In the product: FDA Enforcement

Is there a recent pattern?

An events-per-quarter chart stacks the FDA's enforcement events by source, so a rise in letters or recalls is visible at a glance. The latest events are listed below the chart.

In the product: FDA Enforcement

Was the firm matched to a company, or left unmatched?

An item links to a company page only when a record exists under that name. The rest carry a marker, stay in the list and keep the FDA's own text.

In the product: FDA Enforcement

Where are a firm's GxP facilities, and what do regulators say about them?

The Quality Atlas is a facility-level map and table of GxP manufacturing and distribution sites and what their regulators say about them, with one pin per facility. Pin colors are named in words in the legend as well.

In the product: Quality Atlas

What has a company disclosed, and what is missing?

ESG shows corporate climate targets and workforce and board diversity, extracted from companies' own public disclosures. A value that was not disclosed is shown as not disclosed.

In the product: ESG

Does the quality history sit with the pipeline?

A company page has a Regulatory and Quality lens with its FDA inspections, warning letters, recalls and import refusals. It sits beside the company's programs and financials.

In the product: Companies

Scope

This is the public US FDA record, and an enforcement event is a signal to investigate that says nothing final about a firm's current quality. Items link to a company page only where a record exists under that name, and the rest are marked.

Screen your next supplier during the trial

Every answer above marked "In the product" opens with the Individual plan.

See all plans

Individual plan, $249/seat/mo, card required.

See the other teams

Business development and licensing Screen a licensing target: pipeline, patents, funding and the dates ahead. Clinical operations and feasibility Set enrollment, site and country assumptions from comparable completed trials. Commercial and lifecycle strategy See which revenue faces loss of exclusivity and which programs could replace it. Competitive intelligence and portfolio strategy See who leads a target or indication and what was discontinued. CRO business development Find sponsors active in the indications where your CRO has a record. Clinical outsourcing and CRO selection Shortlist CROs on the trials matched to them. Investors and diligence Financing, ownership, pipeline and FDA history for a company on one page. Medical affairs and KOL mapping Build a KOL shortlist from trial leadership, publications, funding and payments. Translational science and biomarker strategy Tell validated biomarker evidence from association, and trace it to drugs and trials.

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