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FDA compliance

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

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

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
Inspection Readiness

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

Preparing for FDA QSIT Inspections: What to Expect
Medical Devices

Preparing for FDA QSIT Inspections: What to Expect

How to Navigate the FDA Warning Letters Database Successfully
Warning Letters & Enforcement

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

BLA vs NDA vs ANDA cover: the facility gate each FDA application triggers, with 42 of 65 complete response letters in 2024 citing facilities and BLAs drawing 42% of published letters in 2025.
FDA Databases & Guidance

BLA vs NDA: the differences, plus ANDA, 505(b)(2) and biosimilars, and the inspection each one triggers

A comparison of the five FDA marketing application pathways (NDA, 505(b)(2), ANDA, BLA and 351(k) biosimilar) by statute, reviewing center, data required, exclusivity, user fee program and review goal, followed by the part most explainers skip: the pre-approval or pre-license inspection each pathway triggers. Includes Atlas counts of complete response letters by application type (65 in 2024, 48 in 2025, 17 in early 2026), drug vs biologic inspection outcomes from January 2025 to October 2026, and a June 2026 Form 483 at a licensed vaccine maker.

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PDUFA date cover: how FDA sets the goal date (10 months standard, 6 months priority from filing) and why 42 of 65 complete response letters in 2024 cited facility inspections
FDA Databases & Guidance

PDUFA date: how FDA sets the goal date, what moves it, and why facilities miss it

A guide to PDUFA goal dates as of November 2026: what a PDUFA date is, how FDA sets it under the PDUFA VII commitment letter (10 months standard and 6 months priority, counted from the 60-day filing date for NME NDAs and original BLAs), what extends it (major amendments, unlisted facilities), where facility inspections sit on the review clock, and why facility problems appeared in 42 of the 65 complete response letters FDA issued in 2024. Includes Atlas inspection outcome data for drug quality and bioresearch monitoring inspections and a dated table of PDUFA dates sponsors announced for late 2026.

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Release testing in pharma cover: 21 CFR 211.165 cited at 102 of 774 Part 211 drug inspections, with 59.8% of those ending OAI against 22.5% without the citation
CAPA & Quality Systems

Release testing in pharma: what 21 CFR 211.165 requires and what FDA cites

What release testing in pharma means under 21 CFR 211.165 (laboratory testing of every batch against final specifications, microbiological testing, written sampling plans, statistical acceptance criteria, validated methods and rejection of failing batches), how it connects to the 211.192 record review and the quality unit's release decision, how EU Qualified Person certification differs, and what FDA wrote in 109 Form 483 observations at 102 drug inspections from January 2025 to September 2026.

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USP 61 and 62 cover: microbial limits and what FDA cites, with 60 of 774 Part 211 drug inspections citing non-sterile microbiology and 40.0% of those ending OAI, January 2025 to September 2026
CAPA & Quality Systems

USP 61 and 62: microbial limits, the USP 1111 criteria, and what FDA cites

What USP 61 (microbial enumeration) and USP 62 (tests for specified microorganisms) measure, how USP 1111 sets the acceptance limits by route of administration, where USP 51, 71 and 788 fit, and how often FDA cited non-sterile microbiology under 21 CFR 211.113(a), 211.165(b) and 211.84(d)(6) at 774 Part 211 drug inspections that closed January 2025 to September 2026, with named Form 483 examples.

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21 CFR Part 820 after the QMSR: where the old QSR sections went, with 377 device inspections and 39.5% citing risk management.
Medical Devices

21 CFR Part 820 in 2026: the QMSR, where 820.30 and 820.198 went, and what FDA cites

21 CFR Part 820 is FDA's quality management system regulation for medical devices. Since February 2, 2026 it incorporates ISO 13485:2016 by reference and keeps only a few US-specific sections. This guide maps every old Quality System Regulation section to its ISO 13485 home, explains 820.10, 820.35 and 820.45, covers what happened to 820.30 design controls and 820.198 complaint files, and uses Atlas analysis of FDA citation data for 1,124 device inspections from January 2025 to October 2026 to show what investigators cite before and after the change.

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21 CFR 211.192 cover: 296 drug Form 483s cited weak investigations, with 41.2% of those inspections ending OAI against 18.8% without the citation.
CAPA & Quality Systems

21 CFR 211.192: production record review, what FDA cites, and what an investigation file needs

What 21 CFR 211.192 requires (quality unit review of production records before release, and a thorough, written investigation of any unexplained discrepancy that extends to other batches), what counts as an unexplained discrepancy, how FDA words 211.192 observations on Form 483s, which firms drew the citation in 2025 and 2026, how it relates to OAI outcomes, and what a defensible investigation file contains, from 302 observations on 296 drug inspections that closed January 2025 to October 2026.

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The FDA inspection database is six sources, not one: where FDA publishes inspection outcomes, Form 483s, warning letters, import alerts and recalls, and how to join them by FEI number.
FDA Databases & Guidance

FDA inspection database: the six public sources of FDA inspection data, and how to join them

A guide to FDA inspection data as checked in November 2026: the six public sources (Data Dashboard inspections, the FOIA reading room, the warning letter page, Compliance Actions, import alert lists and recall enforcement reports), what each holds and lacks, what happened to the old Inspection Classification Database, and a five-step method for joining them for one facility by FEI number. Includes a worked example (Rohto-Mentholatum Vietnam, from Form 483 to warning letter in 2026) and Atlas counts of Form 483s issued in 2025 by product category.

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FDA registration lookup cover: registered is not approved, with 9,901 registered drug FEIs and 221 OAI outcomes among registered facilities inspected since 2025.
FDA Databases & Guidance

FDA registration lookup: how to check a drug, device or food facility, and what registration proves

A guide to checking whether a company is FDA registered, as of November 6, 2026: the drug registration list (DECRS), the device Registration and Listing database, and food facility registration, which is not public. Covers what registration does and does not prove under 21 CFR 207.77 and 807.39, the renewal windows, and an Atlas join of FDA's November 6, 2026 drug registration file with FDA inspection classifications: 221 of 1,850 registered drug establishments inspected since January 2025 had an OAI outcome. Includes two worked examples that go from a registration hit to the facility's inspection record.

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503B outsourcing facility: what FDA cites on 74 Form 483s at 18 facilities
FDA Databases & Guidance

503B outsourcing facility: definition, 503A vs 503B, and what FDA cites

A 503B outsourcing facility is a sterile compounder that registers with FDA and follows CGMP. This guide covers section 503B of the FD&C Act, registration, the FY2027 establishment fee and twice-yearly product reporting, a 503A vs 503B comparison, how to vet a 503B pharmacy, and the Atlas Form 483 record for 18 registered outsourcing facilities: 74 forms, 457 observations, the 21 CFR sections cited most, and the record of Leiters Health in Englewood, Colorado.

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FDA Data Dashboard: six modules, FEI search and what it leaves out
FDA Databases & Guidance

FDA Data Dashboard: what each module shows, how to search it, and what it leaves out

A practical guide to the FDA Data Dashboard as checked on November 6, 2026: the six compliance dashboards and what each covers, how to look up a facility by FEI number, check a supplier's compliance history, export the data and call the API (endpoints, key, 5,000-row pages), how current each dataset is, and what the dashboard does not show (the observation narrative, investigator names, most Form 483 documents). Includes a comparison with FDA's FOIA reading room, the warning letter page and the Atlas directory, and one facility's citation history read across sources.

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