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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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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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

Regulatory Intelligence

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.

US FDA investigators who inspect Indian facilities: 19 investigators across 292 Form 483s

Regulatory Intelligence

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

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Regulatory Intelligence

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.

Import Alert 66-40 in 2026

Atlas

Regulatory Intelligence

Import Alert 66-40: the 2026 Rohto and TSP Solutions warning letters, and who else is on the list

What FDA Import Alert 66-40 is and how a foreign drug facility lands on it, with the two October 2026 warning letters that followed a 66-40 listing: Rohto Pharmaceutical (for its Rohto-Mentholatum facility in Vietnam, inspected in April 2026) and TSP Solutions in Singapore (reviewed through a 704(a)(4) records request). Includes an Atlas count of the 472 Red List entries by country as of the October 27, 2026 version, a comparison of import alerts and warning letters, and the steps FDA expects before removing a firm.

Reliance Life Sciences Warning Letter

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Regulatory Intelligence

Reliance Life Sciences FDA warning letter 2026: Navi Mumbai data integrity, aseptic practice and the 483s behind it

FDA's drug center sent Reliance Life Sciences a warning letter dated August 18, 2026 for its Rabale, Navi Mumbai facility. This piece covers the two violations, the February 2026 inspection and Form 483 behind them, the recall and Import Alert 66-40 that came first, the facility's 11 FDA inspections and 7 Form 483s in Atlas, and how the findings compare with other Indian drug facilities.

API manufacturer FDA Form 483s 2025 to 2026: by country and most cited sections versus finished dose

Regulatory Intelligence

API 483s: what FDA cites at active pharmaceutical ingredient manufacturers, 2025 to 2026

How FDA inspects active pharmaceutical ingredient manufacturers under FD&C Act section 501(a)(2)(B), Compliance Program 7356.002F and ICH Q7, how API Form 483 observations are written and coded, and what Atlas data show for 47 Form 483s issued at registered API facilities from January 2025 to July 2026: counts by country, the most cited sections, the comparison with 415 finished-dose 483s, and when an API 483 turns into a warning letter.

Eurofins FDA Warning Letter

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Regulatory Intelligence

Eurofins FDA warning letter 2026: microbial data integrity at a contract testing lab

FDA's drug center sent Eurofins SF Analytical Laboratories a warning letter dated October 6, 2026 for incomplete microbiology data at its Horsham, Pennsylvania contract testing laboratory. This piece covers the three violations, the 2022 and 2026 Form 483s behind them, the inspection record of 71 Eurofins facility records in Atlas, how often 22 recent contract lab 483s cite data integrity sections, and what a sponsor should check at its own contract lab.

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

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

Import Alert 66-40: the 2026 Rohto and TSP Solutions warning letters, and who else is on the list

Reliance Life Sciences FDA warning letter 2026: Navi Mumbai data integrity, aseptic practice and the 483s behind it

API 483s: what FDA cites at active pharmaceutical ingredient manufacturers, 2025 to 2026

Eurofins FDA warning letter 2026: microbial data integrity at a contract testing lab

Expert-led insights on
FDA compliance