What counts as a QMSR-era inspection?

An inspection with a published date on or after February 2, 2026, when QMSR took effect. Earlier inspections are Pre-QMSR, and records without a published date read Undetermined rather than being assigned to either regime.

Can we see enforcement history for a specific company?

Yes. FDA submission pages carry an FDA Compliance History section listing linked warning letters and inspection records with their regime, the confidence of the link and a link to FDA.gov. Where no applicant is named, the page says so.

QMSR enforcement

FDA QMSR enforcement: inspection citations, observations and warning letters

The Quality Management System Regulation replaced the Quality System Regulation on February 2, 2026. Enforcement history now spans two regimes, and a citation means something different on each side of that line.

Who it is for: Quality systems, internal audit and compliance teams preparing for inspection, and consultants benchmarking enforcement patterns.

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What is in the workspace today

Enforcement findings

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Regime classification you can argue with

An inspection dated on or after February 2, 2026 is QMSR-era; earlier is Pre-QMSR; no published date is Undetermined. Explicit FDA wording can pull a record back to Pre-QMSR, but nothing is ever promoted to QMSR without a date that supports it — the conservative direction is the only automatic one.

Findings mapped to a controlled taxonomy

Citations and warning-letter findings are mapped to quality-system subject areas — CAPA, complaint handling, design controls, purchasing controls, process validation and the rest — so patterns are comparable across companies and years rather than buried in citation numbers.

Company linking that refuses to guess

A warning letter links to a company only when exactly one company matches the published name. Where a name is shared, every candidate is offered as a Possible link instead of one being picked. Links the data no longer supports are cleaned up on re-run, and FDA Compliance History on an authorization page shows the linked letters and inspections with their regime and link confidence.

Where the data comes from

Only published regulator records, retrieved from official sources. Every screen links back to the record it came from.

FDA inspection citations
Citation counts by reference number and fiscal year, as FDA publishes them.
Open the regulator source
FDA warning letters
Full warning letter text, issuing office, company and issue date.
Open the regulator source
FDA inspection classification data
Inspection records, dates and classifications.
Open the regulator source

What this module does not do

FDA publishes only part of its inspection record, and publishes citations as fiscal-year totals rather than per-inspection counts. Exports say Not published — FDA reports these citations as fiscal-year totals instead of leaving a cell blank.
Citation files for FY2008–FY2013 are published in a legacy spreadsheet format that cannot be read reliably, and are deliberately excluded rather than partially imported.

Questions

What counts as a QMSR-era inspection?: An inspection with a published date on or after February 2, 2026, when QMSR took effect. Earlier inspections are Pre-QMSR, and records without a published date read Undetermined rather than being assigned to either regime.
Can we see enforcement history for a specific company?: Yes. FDA submission pages carry an FDA Compliance History section listing linked warning letters and inspection records with their regime, the confidence of the link and a link to FDA.gov. Where no applicant is named, the page says so.

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