Atlas Blog
Insights on FDA inspections, compliance strategy, and regulatory intelligence from the Atlas team.
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
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
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
Atlas
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.
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
Atlas
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.
A five-phase FDA inspection playbook for drug, biologics and device facilities: the readiness program, day 1 and the Form 482, front room and back room roles with a request log, the Form 483 close-out and annotation under IOM 5.5.11.4, and the 15 business day response, CAPA and EIR. Built on the 2026 IOM and Atlas Form 483 data from the August 15, 2026 release.
Baxter FDA Warning Letter 2026
Atlas
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.
FDA Compounding Warning Letters 2026
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.
Mylan Viatris India FDA Record
Atlas
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.
US FDA Investigator List
Atlas
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.
