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Insights on FDA inspections, compliance strategy, and regulatory intelligence from the Atlas team.

Where to Find FDA 483 Reports (and How to Read One)
FeaturedRegulatory Intelligence

Where to Find FDA 483 Reports (and How to Read One)

There are three routes to an FDA Form 483: FDA's FOIA electronic reading room, a FOIA request, or a searchable database. This guide compares them on coverage, wait time and search, then explains how to read a 483 once you have it, with three recent examples.

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Editor’s Picks

Preparing for FDA Pre-Approval Inspections: A Practical Guide
Inspection Readiness

Preparing for FDA Pre-Approval Inspections: A Practical Guide

FDA Inspection Classifications: VAI, NAI, and OAI Explained
Regulatory Intelligence

NAI, VAI, OAI: What Each FDA Inspection Classification Means

Preparing for FDA QSIT Inspections: What to Expect
Inspection Readiness

Preparing for FDA QSIT Inspections: What to Expect

How to Navigate the FDA Warning Letters Database Successfully
Regulatory Intelligence

FDA Warning Letter Database: How to Search It and Trace a Letter to Its 483

Medical device design controls under the QMSR: which design clauses FDA cited in 2026
Compliance

Medical device design controls under the QMSR: what FDA cites in 2026

Medical device design controls are the documented steps that turn user needs into a verified, validated device design. Since February 2, 2026, FDA enforces them through the QMSR and ISO 13485:2016 clause 7.3 instead of 21 CFR 820.30. This guide maps the old paragraphs to the new clauses, explains verification versus validation and the ISO 14971 risk link, covers what investigators ask for under Compliance Program 7382.850, and uses Atlas data on 389 device Form 483s from 2026 to show which design clauses FDA cites most.

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Computerized system validation: OQ audit trail tests inspectors check
Compliance

Computerized system validation: OQ audit trail tests for life sciences

Computerized system validation is the documented, risk-based evidence that a regulated computer system works as intended and keeps its data trustworthy. This guide covers the expectations in FDA's CSA guidance, Part 11, EMA and ICH E6(R3), a seven-step lifecycle, concrete OQ audit trail test cases, vendor and periodic review controls, and Atlas data on how often FDA cites computerized systems and data integrity.

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FDA 483 vs warning letter: the 15 working day response windows and what 4,584 Form 483s from 2025 show
Regulatory Intelligence

FDA 483 vs warning letter: who gets 15 working days to respond?

A Form FDA 483 is the investigator's list of observations at the close of an inspection. A warning letter is a formal advisory FDA issues later, after review, when it judges violations significant. This guide explains the 15 business day response window for each, how FDA escalates and closes out warning letters, what Atlas data on 4,584 Form 483s from 2025 shows, and how to write a response that survives verification.

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