Atlas Blog
Insights on FDA inspections, compliance strategy, and regulatory intelligence from the Atlas team.
FDA's drug center sent Baxter a warning letter dated September 29, 2026 for its Round Lake, Illinois sterile injectables facility. This piece covers what the letter cites, the March to April 2026 inspection and Form 483 behind it, the earlier 483s at Round Lake, and the Form 483 record across 47 Baxter facility records in Atlas.
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.
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.
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.
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.
What counts as a data integrity citation on an FDA Form 483, which 21 CFR sections FDA uses for it, what ALCOA and ALCOA+ mean in FDA's 2018 guidance, and how often data integrity sections appeared on 779 human drug Form 483s citing Part 211 from January 2025 to July 2026, with US and foreign rates and named examples.
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.
FDA Quality Metrics Program
Atlas
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.
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.
Continued process verification is the ongoing monitoring that shows a validated commercial process stays in a state of control. This guide covers the FDA requirements behind CPV, how often drug 483s cite process monitoring, the metrics worth trending, review frequency, escalation rules, what two 2026 warning letters asked for, and a review checklist.
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.
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.
FDA runs four types of inspections: surveillance, for-cause, application-based (pre-approval and pre-license) and follow-up. This guide explains what triggers each, how FDA picks sites for routine inspections, what a records request in lieu of inspection is, the day-of sequence from Form 482 to the EIR, and what 2,533 Form 483s issued in 2026 show about inspection team size and observation counts.
The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. This guide covers the 2026 edition, its ten chapters, the Chapter 5 sections an inspected firm should read (credentials, Form FDA 482, refusals, photographs, samples, the Form 483 close-out and the EIR), how the IOM differs from the Compliance Program Guidance Manual and the Regulatory Procedures Manual, and what Atlas data show about the investigators who apply it.
An FDA untitled letter is an advisory letter for violations that do not meet the threshold for a warning letter. This guide covers how the Regulatory Procedures Manual separates the two, which FDA offices send untitled letters, the 15 working day response OPDP asks for, how many OPDP letters FDA has posted each year since 2017, and how an untitled letter compares with a Form 483, a warning letter and a regulatory meeting.
