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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

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.

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Eurofins FDA Warning Letter

Atlas

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.

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FDA Compounding Warning Letters 2026

Atlas

Regulatory Intelligence

FDA compounding warning letters in 2026: Empower, SCA and the 503A vs 503B split

What FDA's September 2026 warning letters to Empower Pharmacy (Houston, 503A) and SCA Pharmaceuticals (Little Rock, 503B) cite, how 503A pharmacies and 503B outsourcing facilities differ on CGMP and on compounding copies of approved drugs, when semaglutide and tirzepatide left the shortage list, and what 52 Form 483s issued at registered outsourcing facilities in 2025 and 2026 cite most.

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Mylan Viatris India FDA Record

Atlas

Regulatory Intelligence

Mylan Nashik and Viatris India: FDA inspection history, 483s and warning letters

The FDA inspection record of Mylan Laboratories Limited, the Viatris company, in India: nine facility records, 57 inspections, 35 ending with a Form 483. What FDA cited at Nashik in May 2024, the 2017 Nashik warning letter and its 2018 closeout, the December 2024 warning letter and Import Alert 66-40 at the Indore facility in Pithampur, and the regulations FDA cites most across Mylan's Indian sites.

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US FDA Investigator List

Atlas

Regulatory Intelligence

US FDA investigator list: where the names come from and how to look one up

FDA publishes no public roster of its investigators or auditors. This guide shows where investigator names do appear (credentials, Form FDA 482, the Form 483 signature block, the EIR and FOIA releases), how to look an investigator up in the Atlas directory of 4,996 profiles, which investigators signed the most Form 483s in 2025 and 2026, and how to use an investigator's record in the weeks before an inspection.

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Cleaning validation FDA and EMA requirements, with 21 CFR 211.67 citation data
Regulatory Intelligence

Cleaning validation: FDA and EMA requirements, acceptance limits, and what 483s cite

What FDA and EMA require for cleaning validation: 21 CFR 211.67 and 211.182, FDA's 1993 inspection guide, ICH Q7 section 12.7, EU GMP Annex 15 and the EMA guideline on health-based exposure limits. Covers acceptance limits (HBEL/PDE, 1/1000 dose, 10 ppm), protocols, sampling, hold times and continued verification, with Atlas data on how often 211.67 appears on 2025 and 2026 human drug Form 483s.

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FDA quality agreements: what owners and contract facilities must each control
Regulatory Intelligence

FDA Quality Agreements: What the Guidance Requires and Where Contracts Fail

A quality agreement is the written document in which a drug owner and a contract facility assign each CGMP activity. This guide covers what FDA's November 2016 guidance says, whether a quality agreement is required, a section-by-section checklist, how it differs from a supply agreement, how often 2025 and 2026 human drug Form 483s cite the quality unit section 21 CFR 211.22, and where agreements fail.

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FDA Quality Metrics Program

Atlas

Regulatory Intelligence

The FDA quality metrics program in 2026: practice areas, QMM, and what Form 483s measure

What the FDA quality metrics program is, why reporting is still not required, the four practice areas FDA proposed in 2022 with their example metrics, how the program differs from CDER's voluntary Quality Management Maturity assessments, and which 21 CFR Part 211 sections FDA investigators cited in each practice area across 779 human drug Form 483s issued from January 2025 to July 2026.

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510(k) submission guide: the path from predicate to clearance and what FDA inspects after
Regulatory Intelligence

510(k) submission guide: what a 510(k) is, how FDA reviews it, and what inspectors check after clearance

A 510(k) is the premarket notification a device maker files with FDA to show a new device is substantially equivalent to a legally marketed predicate. This guide covers who must submit, the exemptions, Traditional, Special and Abbreviated 510(k)s, eSTAR, acceptance review and Additional Information holds, the 90 FDA day decision goal, how 510(k) compares with De Novo and PMA, when a change to a cleared device needs a new 510(k), and what Atlas data on 389 device Form 483s from 2026 shows about the design changes inspectors check after clearance.

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FDA combination products: the three types, primary mode of action and the cGMP rules in 21 CFR Part 4
Regulatory Intelligence

Combination products: the FDA definition, PMOA and the Part 4 cGMP rules

A combination product combines a drug, device or biological product into one product, one package or a cross-labeled pair. This guide covers the FDA definition in 21 CFR 3.2(e), the three types with examples, how primary mode of action decides the lead center, the Request for Designation, the 21 CFR Part 4 cGMP options as rewritten for the QMSR, postmarketing safety reporting under Part 4 subpart B, and what Atlas found in 193 Form 483s issued to 15 combination product makers.

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FDA foreign inspections: Form 483s issued outside the US by country, 2025 and 2026
Regulatory Intelligence

FDA foreign inspections in 2026: unannounced visits, the refusal rule, and the Form 483s by country

FDA inspects about 3,000 foreign facilities a year and now arrives at most Indian sites without notice. This guide covers the legal basis, what refusing or limiting an inspection triggers, 704(a)(4) records requests and Import Alert 66-79, and Atlas data on every Form 483 issued from January 2025 to July 2026 by country, including the regulations cited most often at Indian drug facilities.

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