What FDA is citing, by regulation
Start from the regulation you are being measured against. Each hub collects every DSRV article whose snapshot cites it, with the enforcement case, the inspection exposure it created, and the desk’s take.
65 regulations · 47 articles with a Regulatory Snapshot
21 CFR 211.192
14 articles10 high · 4 moderateLatest: Bentley Widened the pH Limit Instead of Finding the Cause
DSRV service · Investigation Defensibility Audit
21 CFR 211.22
7 articles5 high · 2 moderateLatest: FDA Is Treating Discarded Evidence as a Quality Unit Failure
ICH Q10
7 articles3 high · 3 moderate · 1 lowLatest: FDA Finally Wrote Down What a Good 483 Response Requires
21 CFR 211.100
5 articles5 highLatest: Your Next 483 Observation Is Running on a Timer
ICH Q9(R1)
5 articles2 high · 2 moderate · 1 lowLatest: ICH Q8/Q9/Q10 R5 Just Raised the Floor on Risk Documentation
DSRV service · Quality Risk Management Tune-up
21 CFR 211.22(c)
4 articles3 high · 1 moderateLatest: Your Next 483 Observation Is Running on a Timer
21 CFR 211.166
3 articles1 high · 2 moderateLatest: Media-Fill Failure Is Not the Root Cause. It Is the Alarm Bell.
21 CFR 211.84
3 articles2 high · 1 moderateLatest: A Quality Unit That Averaged Away Its Own OOS Failures
21 CFR 211.84(d)(2)
3 articles3 highLatest: Bentley Widened the pH Limit Instead of Finding the Cause
21 CFR Part 11
3 articles1 high · 2 moderateLatest: Your Next 483 Observation Is Running on a Timer
21 CFR Part 211
3 articles3 highLatest: COAs Are Not Component Verification. Five FDA Warning Letters Just Said So.
21 CFR Parts 210/211
3 articles2 high · 1 moderateLatest: FDA’s 2025–2026 Warning-Letter Pattern: Water Systems Are Still Breaking Quality Systems, Not Just Utilities
ICH Q1A(R2)
3 articles3 moderateLatest: What Evidence Supports a Stability Justification?
21 CFR 211.100(a)
2 articles2 highLatest: Bentley Widened the pH Limit Instead of Finding the Cause
21 CFR 211.165
2 articles1 high · 1 moderateLatest: Media-Fill Failure Is Not the Root Cause. It Is the Alarm Bell.
DSRV service · Release Testing / RTRT Readiness
21 CFR 211.194(a)
2 articles2 highLatest: FDA Is Treating Discarded Evidence as a Quality Unit Failure
21 CFR 211.67
2 articles2 highLatest: FDA Tied Residue, Cleaning Validation, and Component Controls at Chemco
DSRV service · Cleaning Validation Risk Review
21 CFR 211.68
2 articles2 highLatest: Your Next 483 Observation Is Running on a Timer
21 CFR 211.68(b)
2 articles2 highLatest: FDA Data Integrity Violations Keep Repeating. This Is Why.
21 CFR 211.84(d)(1)
2 articles2 highLatest: Bentley Widened the pH Limit Instead of Finding the Cause
ICH Q12
2 articles2 moderateLatest: Your Stability Program Was Built for a Guideline Stack FDA Is Replacing
ICH Q1E
2 articles2 moderateLatest: What Evidence Supports a Stability Justification?
ICH Q7
2 articles2 highLatest: The Certificate of Analysis Is Not a Test
21 CFR 11.10(a)
1 article1 moderateLatest: What Pharma Quality Teams Need to Know About MCP Governance
21 CFR 11.10(d)
1 article1 moderateLatest: What Pharma Quality Teams Need to Know About MCP Governance
21 CFR 11.10(e)
1 article1 moderateLatest: What Pharma Quality Teams Need to Know About MCP Governance
21 CFR 211.113(b)
1 article1 highLatest: Media-Fill Failure Is Not the Root Cause. It Is the Alarm Bell.
21 CFR 211.160
1 article1 highLatest: Media-Fill Failure Is Not the Root Cause. It Is the Alarm Bell.
21 CFR 211.160(b)
1 article1 highLatest: Contract Testing Labs Keep Exposing GMP Control Gaps
21 CFR 211.165(b)
1 article1 highLatest: Contract Testing Labs Keep Exposing GMP Control Gaps
21 CFR 211.180(a)
1 article1 highLatest: FDA Data Integrity Enforcement Is Accelerating — Here's What the Warning Letters Actually Say
21 CFR 211.194
1 article1 highLatest: What FDA's Data Integrity Remediation Demands Actually Reveal
21 CFR 211.42
1 article1 highLatest: Multi-Product API Facilities and the Contamination Gap FDA Finds
21 CFR 211.46
1 article1 highLatest: Multi-Product API Facilities and the Contamination Gap FDA Finds
21 CFR 211.48
1 article1 highLatest: FDA’s 2025–2026 Warning-Letter Pattern: Water Systems Are Still Breaking Quality Systems, Not Just Utilities
21 CFR 211.67(a)
1 article1 highLatest: Your Complaint Investigation Is Closed. FDA Says the Risk Is Not.
21 CFR 211.84(d)
1 article1 highLatest: FDA Found Zero Asbestos Testing at Five OTC Manufacturers
21 CFR 7.40
1 article1 moderateLatest: What a Recall and a Closeout Letter Say About Quality Systems: Hidden Sildenafil, CAPA Sustainability, and Inspection Readiness
21 CFR 820
1 article1 highLatest: Four Months Under QMSR: Risk Management Is FDA's Top Citation
21 CFR 820.100
1 article1 highLatest: The CAPAs Were Filed. The Problem Kept Recurring.
EU GMP
1 article1 moderateLatest: EU AI Act Delays High-Risk Deadline to December 2027
EU GMP Annex 11
1 article1 moderateLatest: What Pharma Quality Teams Need to Know About MCP Governance
EudraLex Volume 4 Annex 22 (draft)
1 article1 moderateLatest: EU AI Act Delays High-Risk Deadline to December 2027
FDA draft guidance Docket FDA-2025-D-1106
1 article1 moderateLatest: Your Stability Program Was Built for a Guideline Stack FDA Is Replacing
FDA draft guidance on Form 483 responses (March 2026)
1 article1 moderateLatest: Your 483 Response Has 15 Business Days. FDA Just Defined the Bar.
FDA draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (2026)
1 article1 highLatest: FDA Just Told You Exactly What It Expects in a 483 Response
FDA draft guidance: Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
1 article1 moderateLatest: FDA Finally Wrote Down What a Good 483 Response Requires
FDA guidance ICH Q8/Q9/Q10 Questions and Answers (R5)
1 article1 moderateLatest: ICH Q8/Q9/Q10 R5 Just Raised the Floor on Risk Documentation
FDA guidance Identifying Trading Partners Under the Drug Supply Chain Security Act
1 article1 highLatest: DSCSA Enforcement Just Reached Your Medical Spa
FDA guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
1 article1 highLatest: The One FDA Request You Cannot Refuse
ICH Q1 (draft consolidated guideline)
1 article1 moderateLatest: Your Stability Program Was Built for a Guideline Stack FDA Is Replacing
ICH Q14
1 article1 moderateLatest: ICH Q14 Analytical Procedure Development: What QA Teams Need to Know
DSRV service · Analytical Lifecycle Readiness Check
ICH Q1B
1 article1 moderateLatest: What Evidence Supports a Stability Justification?
ICH Q1D
1 article1 moderateLatest: When Stability Data Gaps Become Inspection Exposure
ICH Q2(R2)
1 article1 moderateLatest: ICH Q14 Analytical Procedure Development: What QA Teams Need to Know
ICH Q5C
1 article1 moderateLatest: Your Stability Program Was Built for a Guideline Stack FDA Is Replacing
ICH Q7 Section 12.7
1 article1 highLatest: Multi-Product API Facilities and the Contamination Gap FDA Finds
ICH Q8
1 article1 moderateLatest: FDA's Evolving Stance on Real-Time Release Testing (RTRT)
ICH Q8(R2)
1 article1 moderateLatest: ICH Q8/Q9/Q10 R5 Just Raised the Floor on Risk Documentation
ICH Q9
1 article1 moderateLatest: FDA Finally Wrote Down What a Good 483 Response Requires
DSRV service · Quality Risk Management Tune-up
ISO 13485
1 article1 highLatest: Four Months Under QMSR: Risk Management Is FDA's Top Citation
NAFDAC 5+5 Policy
1 article1 highLatest: 108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.
USP
1 article1 highLatest: COAs Are Not Component Verification. Five FDA Warning Letters Just Said So.
WHO-PQ
1 article1 highLatest: 108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.
WHO-PQ GMP Guidelines
1 article1 highLatest: 108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.
New to a term? The glossary defines 483, OOS, CAPA, data integrity and the rest from the official source and points back to these hubs. Regulatory intelligence and interpretation, not legal advice. Verify against the official FDA or ICH source each article names. The same data is available to agents at /api/regulatory-snapshots.