Atlas Blog

Expert-led insights on
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)

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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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.

21 CFR Part 211 cover: all 11 subparts mapped to how often FDA cites each on 779 human drug Form 483s, January 2025 to July 2026

GMP & GxP Compliance

21 CFR Part 211: the 11 subparts and what FDA cites under each

What 21 CFR Part 211 is, who it applies to, the 11 subparts and 60 sections, how Part 210 differs from Part 211, and how often FDA investigators cite each subpart on human drug Form 483s, from 779 forms issued January 2025 to July 2026 in the Atlas Form 483 directory.

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.

FEI number explained: the FDA Establishment Identifier, with 25,680 facilities inspected from January 2025 to October 2026 and 86.2% carrying a 10-digit FEI

FDA Databases & Guidance

FEI number: what it is, how to find yours, and what it tells you about a facility

What an FDA Establishment Identifier (FEI) is, how it differs from an EIN, a DUNS number, an FDA registration number and the retired CFN, what FEI numbers look like across 25,680 facilities FDA inspected from January 2025 to October 2026, how to find or request an FEI, and how to pull a facility's Form 483s and inspection history by FEI.

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.

ALCOA principles: what FDA cites on 1 in 4 drug Form 483s

Data Integrity & CSV

ALCOA principles: ALCOA and ALCOA+ explained with FDA Form 483 data

What ALCOA stands for, what ALCOA+ and ALCOA++ add and which regulator defines each, the 21 CFR sections FDA cites when a record fails an attribute, how often those sections appeared on 779 human drug Form 483s from January 2025 to July 2026, named Form 483s with data integrity citations, and a five-step ALCOA self-inspection.

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.

FDA MAUDE database guide: how to search it, its limits, and 4,622 device Form 483s

Medical Devices

FDA MAUDE database: how to search it, what it misses, and what inspectors cite

What the FDA MAUDE database holds, who must file medical device reports under 21 CFR Part 803, how simple and advanced search work, the known limits of MAUDE data, and the AEMS transition. Atlas Form 483 data shows how often FDA investigators cite MDR and complaint-handling failures at device facilities, with named Form 483s and the October 2026 Olympus warning letter.

Gland Pharma FDA inspection history and the Dundigal Form 483 of October 2026

Company Inspection Histories

Gland Pharma FDA inspection history: the Dundigal 483, every facility and Cenexi

The FDA inspection record of Gland Pharma and its Cenexi subsidiary: nine facility records in India, France and Belgium, 48 inspections, 30 ending with a Form 483. What Gland disclosed about the October 2026 Form 483 at the Dundigal formulation facility in Hyderabad, what is not public yet, each facility's record, the sterile-processing citation FDA repeats across the group, and what happens next.

GMP audits: types, auditors, and what FDA cites on 779 drug Form 483s

Supplier Quality

GMP audits: types, auditors, and what FDA cites that internal audits miss

What a GMP audit is, the four audit types and the rules behind each (EU GMP Chapter 9, ICH Q7 and Q10, 21 CFR 211.84), who can act as a GMP auditor, how often to audit, the seven steps of an audit, a per-system audit scope, and what FDA investigators cite on human drug Form 483s that internal audits tend to miss, from 779 Part 211 forms issued January 2025 to July 2026.

Granules India FDA inspection history and the Gagillapur Form 483 of October 2026

Company Inspection Histories

Granules India USFDA Gagillapur inspection: 11 observations and the full FDA record

The October 2026 USFDA inspection of Granules India's Gagillapur finished dosage facility ended with a Form 483 listing 11 observations. What Granules disclosed, how the shares moved, what happens next, the February 2025 warning letter it follows, and the full FDA record across ten Granules facility records: 41 inspections, 23 ending with a Form 483, including ten at Granules Pharmaceuticals Inc. in Chantilly, Virginia.

MHRA inspection vs FDA inspection: how UK GMP inspections grade deficiencies

Inspection Readiness

MHRA inspection vs FDA: how GMP deficiencies are graded, and what FDA cites in the UK

What the MHRA is, how an MHRA GMP inspection runs from risk rating to post-inspection letter, how deficiencies are graded critical, major or other, and what happens at the Inspection Action Group. MHRA's 2019 deficiency dataset is set against Atlas Form 483 data, the US-UK mutual recognition agreement, and FDA's inspection record at 1,155 UK facilities.

What is CDER: FDA's drug center, CDER vs CBER, and who signs drug warning letters

FDA Databases & Guidance

What is CDER? The FDA drug center explained for manufacturers

What the FDA's Center for Drug Evaluation and Research (CDER) is, what it regulates, which offices matter to a manufacturer, and how it differs from CBER, CDRH and the Office of Inspections and Investigations (OII). Atlas data shows CDER now signs every drug CGMP warning letter after the 2024 ORA reorganization, and how many Form 483s go to human drug and biologics facilities each year.

FDA Investigators

US FDA auditor list for India: the investigators behind 292 Form 483s, 2024 to 2026

FDA publishes no list of the investigators it sends to India. Atlas rebuilt one from 292 Form 483s issued to Indian facilities from January 2024 to July 2026: the 19 investigators named on five or more, the sections they cite, how FDA staffs India inspections through its New Delhi office and US-based investigators, and how a facility finds out who is coming.

FDA Warning Letters October 2026

Atlas

Warning Letters & Enforcement

FDA warning letters October 2026: all 18 drug and device CGMP letters

All 18 drug and device CGMP and QSR warning letters FDA posted in October 2026, with letter numbers, issue and posting dates, the 21 CFR sections cited, the five recipients already on Import Alert 66-40, and the Form 483 record Atlas holds for each inspected facility.

Expert-led insights onFDA compliance

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

Editor’s Picks

Preparing for FDA Pre-Approval Inspections: A Practical Guide

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

Preparing for FDA QSIT Inspections: What to Expect

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

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

21 CFR Part 211: the 11 subparts and what FDA cites under each

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

FEI number: what it is, how to find yours, and what it tells you about a facility

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

ALCOA principles: ALCOA and ALCOA+ explained with FDA Form 483 data

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

FDA MAUDE database: how to search it, what it misses, and what inspectors cite

Gland Pharma FDA inspection history: the Dundigal 483, every facility and Cenexi

GMP audits: types, auditors, and what FDA cites that internal audits miss

Granules India USFDA Gagillapur inspection: 11 observations and the full FDA record

MHRA inspection vs FDA: how GMP deficiencies are graded, and what FDA cites in the UK

What is CDER? The FDA drug center explained for manufacturers

US FDA auditor list for India: the investigators behind 292 Form 483s, 2024 to 2026

FDA warning letters October 2026: all 18 drug and device CGMP letters

Expert-led insights on
FDA compliance