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21 CFR 211.194
Every DSRV article whose Regulatory Snapshot cites 21 CFR 211.194: 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 211.194?
- 1 DSRV article cite 21 CFR 211.194. Enforcement cases behind them: FDA Warning Letter 707857 to Shiva Analyticals Private Limited, July 23, 2025, read alongside warning letters to Global Calcium Pvt. Limited (January 16, 2025), Landy International (June 12, 2024), and A. Nelson and Co. Ltd. (February 12, 2026). Inspection exposure across them: 1 high.
- What does DSRV recommend for 21 CFR 211.194?
- From the newest article (What FDA's Data Integrity Remediation Demands Actually Reveal): FDA's remediation demands, read in reverse, are a published specification of baseline CGMP: enabled and reviewed audit trails, individual role-limited access, formally retained raw data, and a quality unit that surfaces data integrity anomalies before an inspector does. DSRV is decision support, not legal advice; verify against the official source each article names.
In brief
Address this risk
Pressure-test your evidence before an inspector reads it
Bring the document that has to hold up under 21 CFR 211.194. 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.