Browse by regulation1 article · 1 high
21 CFR §211.67
Every DSRV article whose Regulatory Snapshot cites 21 CFR §211.67: the enforcement case behind it, the inspection exposure it created, and what the desk would do about it.
Inspection exposure across the set
- What has FDA cited under 21 CFR §211.67?
- 1 DSRV article cite 21 CFR §211.67. Enforcement cases behind them: ICH Q9(R1) Quality Risk Management (revised 2023); recurring FDA 483 cleaning-validation observations. Inspection exposure across them: 1 high.
- What does DSRV recommend for 21 CFR §211.67?
- From the newest article (Risk-Based Cleaning Validation: Applying ICH Q9 Principles in Practice): A risk-based cleaning program is defensible only when worst-case selection and acceptance limits trace back to a documented risk assessment. DSRV's matching service is the Cleaning Validation Risk Review, delivered through controlled intake at /submit. DSRV is decision support, not legal advice; verify against the official source each article names.
In brief
Address this risk
Cleaning Validation Risk Review
Bring the document that has to hold up under 21 CFR §211.67. DSRV maps the evidence, names the gaps, and routes judgment calls to human review. Controlled intake, no public file upload.
Regulatory intelligence and interpretation, not legal advice. Verify against the official FDA or ICH source each article names.