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.
29 regulations · 21 articles with a Regulatory Snapshot
21 CFR 211.192
6 articles5 high · 1 moderateLatest: A Quality Unit That Averaged Away Its Own OOS Failures
DSRV service · Investigation Defensibility Audit
ICH Q10
5 articles3 high · 1 moderate · 1 lowLatest: 108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.
21 CFR 211.100
3 articles3 highLatest: Your Next 483 Observation Is Running on a Timer
21 CFR 211.22(c)
3 articles3 highLatest: 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 Q9(R1)
3 articles1 high · 1 moderate · 1 lowLatest: Where AI Can Safely Support Pharma Quality Teams
DSRV service · Quality Risk Management Tune-up
21 CFR §211.166
2 articles2 moderateLatest: What Evidence Supports a Stability Justification?
ICH Q1A(R2)
2 articles2 moderateLatest: What Evidence Supports a Stability Justification?
21 CFR §211.165
1 article1 moderateLatest: FDA's Evolving Stance on Real-Time Release Testing (RTRT)
DSRV service · Release Testing / RTRT Readiness
21 CFR §211.67
1 article1 highLatest: Risk-Based Cleaning Validation: Applying ICH Q9 Principles in Practice
DSRV service · Cleaning Validation Risk Review
21 CFR 211.100(a)
1 article1 highLatest: A Quality Unit That Averaged Away Its Own OOS Failures
21 CFR 211.194(a)
1 article1 highLatest: FDA Is Treating Discarded Evidence as a Quality Unit Failure
21 CFR 211.22
1 article1 highLatest: FDA Is Treating Discarded Evidence as a Quality Unit Failure
21 CFR 211.48 / 21 CFR 211.192
1 article1 highLatest: FDA’s 2025–2026 Warning-Letter Pattern: Water Systems Are Still Breaking Quality Systems, Not Just Utilities
21 CFR 211.68
1 article1 highLatest: Your Next 483 Observation Is Running on a Timer
21 CFR 211.84
1 article1 highLatest: A Quality Unit That Averaged Away Its Own OOS Failures
21 CFR Part 11
1 article1 highLatest: Your Next 483 Observation Is Running on a Timer
ICH Q12
1 article1 moderateLatest: ICH Q14 Analytical Procedure Development: What QA Teams Need to Know
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 Q1E
1 article1 moderateLatest: What Evidence Supports a Stability Justification?
ICH Q2(R2)
1 article1 moderateLatest: ICH Q14 Analytical Procedure Development: What QA Teams Need to Know
ICH Q8
1 article1 moderateLatest: FDA's Evolving Stance on Real-Time Release Testing (RTRT)
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 / ICH Q10
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.