What has FDA cited under 21 CFR 820.100?

1 DSRV article cite 21 CFR 820.100. Enforcement cases behind them: FDA Warning Letters to Medline Industries, LP, CMS Case 723866, March 25, 2026, and Intas Pharmaceuticals Limited, CMS Case 721151, March 30, 2026. Inspection exposure across them: 1 high.

What does DSRV recommend for 21 CFR 820.100?

From the newest article (The CAPAs Were Filed. The Problem Kept Recurring.): FDA has moved past asking whether a CAPA procedure exists to asking whether closed CAPAs changed outcomes, so any failure type that recurs within a year of closure is standing evidence that the root cause was never correctly identified. DSRV is decision support, not legal advice; verify against the official source each article names.

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21 CFR 820.100

Every DSRV article whose Regulatory Snapshot cites 21 CFR 820.100: 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 820.100?: 1 DSRV article cite 21 CFR 820.100. Enforcement cases behind them: FDA Warning Letters to Medline Industries, LP, CMS Case 723866, March 25, 2026, and Intas Pharmaceuticals Limited, CMS Case 721151, March 30, 2026. Inspection exposure across them: 1 high.
What does DSRV recommend for 21 CFR 820.100?: From the newest article (The CAPAs Were Filed. The Problem Kept Recurring.): FDA has moved past asking whether a CAPA procedure exists to asking whether closed CAPAs changed outcomes, so any failure type that recurs within a year of closure is standing evidence that the root cause was never correctly identified. DSRV is decision support, not legal advice; verify against the official source each article names.

May 20265 min readHigh exposurecited as a tag
The CAPAs Were Filed. The Problem Kept Recurring.
Two FDA warning letters from March 2026 cite Medline Industries and Intas Pharmaceuticals not for missing CAPA systems but for CAPA responses that failed to match the size of the problem. The distinction is one most quality teams have not fully internalized.
Case
FDA Warning Letters to Medline Industries, LP, CMS Case 723866, March 25, 2026, and Intas Pharmaceuticals Limited, CMS Case 721151, March 30, 2026.
DSRV take
FDA has moved past asking whether a CAPA procedure exists to asking whether closed CAPAs changed outcomes, so any failure type that recurs within a year of closure is standing evidence that the root cause was never correctly identified.

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Regulatory intelligence and interpretation, not legal advice. Verify against the official FDA or ICH source each article names.