Atlas

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)
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.

Read article

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

Revised Schedule M vs US CGMP cover: 13 Parts in the rule, 2,574 Indian facilities in the Atlas FDA record, and 14% of Indian drug quality inspections classified OAI against 19% in the US.
GMP & GxP Compliance

Schedule M (India GMP) vs US CGMP: the revised rule, clause by clause, with FDA data from India

What revised Schedule M of India's Drugs Rules, 1945 requires, read from Gazette notification G.S.R. 922(E) and its later amendments: the 13 Parts, the turnover-based deadlines and the December 31, 2025 extension for small and medium manufacturers. The rule is set clause by clause against 21 CFR Part 211, then against FDA's record at Indian drug facilities: 257 drug quality inspections from January 2025 to October 2026, their NAI, VAI and OAI split, and the Part 211 sections cited most.

Read more
Aseptic processing cover: 98 of 774 FDA Part 211 drug inspections cited 21 CFR 211.113(b) from January 2025 to September 2026, with 54.1% ending OAI and 62.2% also citing 211.192.
Inspection Readiness

Aseptic processing: FDA guidance, the 211.113(b) record, and what investigators cite

What aseptic processing is and how it differs from terminal sterilization, what FDA's 2004 aseptic processing guidance and 21 CFR 211.113(b) and 211.42(c)(10) require, how FDA investigators worded the 211.113(b) citation at 98 of 774 Part 211 drug inspections from January 2025 to September 2026, which sections came with it, and the six files that make up a defensible 211.113(b) record.

Read more
Process validation cover: FDA's three stages from the 2011 guidance, with 275 of 774 Part 211 drug inspections citing 21 CFR 211.100 or 211.110 and 43.6% of those ending OAI, January 2025 to September 2026.
CAPA & Quality Systems

Process validation: FDA's three stages, the batch question, and what 483s cite

What process validation is, the three stages in FDA's January 2011 guidance (process design, process qualification, continued process verification), how many PPQ batches FDA and EU GMP Annex 15 expect, how process validation differs from IQ, OQ and PQ, and how often FDA investigators cited 21 CFR 211.100 and 211.110 at 774 drug inspections that closed between January 2025 and September 2026.

Read more
USP 797 cover: Category 1, 2 and 3 sterile compounding rules read against 280 FDA Form 483s at 187 pharmacies and outsourcing facilities, with environmental monitoring on 52.9% of forms, 2013 to 2026.
Warning Letters & Enforcement

USP 797: the 2023 categories, beyond-use dates, and what FDA cites at sterile compounders

USP 797 is the United States Pharmacopeia chapter that sets the minimum standards for compounding sterile preparations. This guide covers the November 2023 revision: Category 1, 2 and 3 CSPs, beyond-use dates, engineering controls, environmental monitoring, cleaning and personnel qualification, who enforces the chapter, and what FDA cited on 280 sterile compounding Form 483s at 187 pharmacies and outsourcing facilities from February 2013 to June 2026, from the Atlas Form 483 directory.

Read more
USP 800 cover: hazardous drug handling rules and what FDA cites, with 50 of 397 compounding pharmacy Form 483s carrying a hazardous or highly potent drug containment heading, 2013 to 2026.
Warning Letters & Enforcement

USP 800: the hazardous drug rules and what FDA cites at compounders

USP General Chapter 800 sets the standard for handling hazardous drugs in healthcare settings. This guide covers the NIOSH 2024 list, the assessment of risk, containment engineering controls, PPE, deactivation and cleaning, who enforces the chapter (state boards, not FDA), and what the Atlas Form 483 directory shows: 50 of 397 Form 483s issued to compounding pharmacies from 2013 to 2026 carry a hazardous or highly potent drug containment heading.

Read more
Atlas cover for 21 CFR Part 803: medical device reporting deadlines for manufacturers, importers and user facilities, with 2,231 of 10,321 device Form 483s citing Part 803.
Medical Devices

21 CFR Part 803: medical device reporting rules, deadlines, and what FDA cites

21 CFR Part 803, FDA's medical device reporting (MDR) regulation, explained section by section: who must report, what counts as a reportable event, the 30-day, 5-day and 10-work-day deadlines, eMDR submission, MDR procedures and event files. Atlas Form 483 data shows which Part 803 sections FDA investigators cite at device facilities, how often, and how the share has moved since 2013, with named Form 483 examples.

Read more
Bioburden testing cover: pre-filtration and per-device limits, ISO 11737-1, and the contamination citations behind 129 FDA drug inspections, 50.4% of them ending OAI, and 56 device inspections, January 2025 to October 2026.
CAPA & Quality Systems

Bioburden testing: limits, ISO 11737 and what FDA cites

What bioburden is, how drug manufacturers test it before sterile filtration and terminal sterilization under 21 CFR 211.113, how device manufacturers measure it per device under ISO 11737-1 and use it to set the sterilization dose, what limits apply, and how often FDA cited contamination and sterilization controls at 774 Part 211 drug inspections and 1,124 device inspections that closed January 2025 to October 2026, with named Form 483 examples.

Read more
Endotoxin testing cover: LAL, rFC and what FDA cites, with 98 of 774 Part 211 drug inspections citing sterile process controls under 21 CFR 211.113(b) and 54.1% of those ending OAI, January 2025 to September 2026.
CAPA & Quality Systems

Endotoxin testing: LAL methods, rFC, the K/M limit and what FDA cites

What endotoxin testing is, how the bacterial endotoxins test (USP 85, Ph. Eur. 2.6.14) works with gel clot, turbidimetric and chromogenic LAL methods, where recombinant factor C and recombinant cascade reagents stand under USP 86 and Ph. Eur. 2.6.32, how the K/M endotoxin limit and the maximum valid dilution are calculated, FDA's device limits from its March 2026 questions and answers guidance, and how FDA cited endotoxin and sterile process controls at 774 Part 211 drug inspections from January 2025 to September 2026.

Read more
EU GMP Annex 1 cover: the 2022 sterile manufacturing rules set against FDA findings, with 6 of 165 FDA drug quality inspections at EU facilities ending OAI and 3 of those at sterile sites citing aseptic rules, January 2025 to October 2026.
Inspection Readiness

EU GMP Annex 1: the 2022 requirements and what FDA cites at EU sterile facilities

What EU GMP Annex 1 is, what the 2022 revision changed, what a contamination control strategy must cover, whether PUPSIT is mandatory, what cleanroom grades A to D mean, how Annex 1 relates to FDA's 21 CFR 211 rules, and what FDA investigators cited when they inspected sterile facilities in the EU between January 2025 and October 2026, from FDA inspection classifications and the Atlas Form 483 citation dataset.

Read more
IQ OQ PQ cover: equipment qualification explained, with 383 of 774 Part 211 drug inspections citing equipment design, maintenance or calibration and 33.7% of those ending OAI, January 2025 to September 2026.
CAPA & Quality Systems

IQ OQ PQ: what each equipment qualification proves, and what FDA cites

What installation, operational and performance qualification (IQ, OQ, PQ) each prove, where design qualification and FAT/SAT fit, what a qualification protocol contains, how qualification differs from validation, and how often FDA cites equipment design, maintenance and calibration (21 CFR 211.63, 211.67, 211.68) on drug Form 483s, with device equivalents, from 774 Part 211 drug inspections that closed January 2025 to September 2026.

Read more
QMSR for device teams: 349 FDA device Form 483s from 131 investigators between February 2 and July 17, 2026, with risk management wording on 31.5% of them.
Medical Devices

QMSR: what FDA's Quality Management System Regulation changed for device teams in 2026

The QMSR, FDA's Quality Management System Regulation, replaced the Quality System Regulation for medical devices on February 2, 2026. This guide covers what changed in day-to-day practice: the new names for design, device and batch records, management review and audit reports that investigators can now read, Compliance Program 7382.850 in place of QSIT, and what a device team should do now. It adds Atlas data on the first months: 349 device Form 483s from 131 investigators, the January 2026 inspection dip, and the wording FDA uses on management review and internal audit citations.

Read more
What happens during an FDA inspection, step by step: drug inspections that end in a Form 483 last a median of 5 days, and the EIR arrives a median of 77 days later.
Inspection Readiness

What happens during an FDA inspection: the process, step by step

The FDA inspection process step by step: the Form FDA 482, opening meeting, floor tour, records review, daily debriefs, the Form 483 closeout and the NAI, VAI or OAI classification. With Atlas data on inspection length from 2,245 facility records, investigator team size and observations per Form 483, and FDA classification data on 35,021 inspections ending January 2025 to October 2026, including the median 77 days from a drug inspection's end to EIR release.

Read more
503A compounding pharmacy cover: what section 503A requires and what 280 FDA Form 483s at 204 compounding pharmacies cite, with environmental monitoring on 33% of forms, 2009 to April 2026.
Warning Letters & Enforcement

503A compounding pharmacy: the FDA rules and what 280 Form 483s cite

A 503A compounding pharmacy is a state-licensed pharmacy that compounds drugs for identified patients under section 503A of the FD&C Act. This guide covers the seven statutory conditions, the bulk drug substance and ingredient sourcing rules, the copies limit, the health system common ownership policy, when FDA inspects a 503A pharmacy, and the Atlas Form 483 record for 204 compounding pharmacies: 280 forms and 1,967 observations from 2009 to April 2026.

Read more
Bachem FDA inspection history: 37 FDA inspections at Torrance, Vista, Bubendorf and Vionnaz, 16 ending in a Form 483, with both May 2026 US inspections classified VAI.
Company Inspection Histories

Bachem FDA inspection history: Torrance, Vista and every Form 483

The FDA inspection record of Bachem, the peptide and oligonucleotide manufacturer: four facility records in California and Switzerland, 37 inspections from 2001 to 2026, 16 ending with a Form 483. Each facility's history, the two May 2026 inspections at Torrance and Vista and their VAI classifications, what the one public Form 483 cites, the investigators on the record, and what a supplier file on Bachem should hold.

Read more