21 CFR 211.100(a)
Every DSRV article whose Regulatory Snapshot cites 21 CFR 211.100(a): the enforcement case behind it, the inspection exposure it created, and what the desk would do about it.
- What has FDA cited under 21 CFR 211.100(a)?
- 2 DSRV articles cite 21 CFR 211.100(a). Enforcement cases behind them: FDA Warning Letter 320-26-126 (MARCS-CMS 732028) to Bentley Laboratories LLC, 111 Fieldcrest Avenue, Edison, NJ (FEI 2244819); inspected 03/16-03/27/2026, issued 09/17/2026, posted 09/29/2026; FDA Warning Letter CMS Case 732115 to ABS Corporation, July 23, 2026. Inspection exposure across them: 2 high.
- What does DSRV recommend for 21 CFR 211.100(a)?
- From the newest article (Bentley Widened the pH Limit Instead of Finding the Cause): A CAPA that changes the limit and leaves the cause alone closes the record and keeps the risk. The file an inspector wants shows what caused the result, which other lots it reaches, and a limit change justified by data dated independently of the failure. DSRV is decision support, not legal advice; verify against the official source each article names.
- 6 min readHigh exposurecited as a tag
Bentley Widened the pH Limit Instead of Finding the Cause
FDA's warning letter to Bentley Laboratories says an out-of-specification pH result at 36 months was answered with a wider specification range and no scientific justification. The same letter shows what an OOS investigation has to contain.
- Case
- FDA Warning Letter 320-26-126 (MARCS-CMS 732028) to Bentley Laboratories LLC, 111 Fieldcrest Avenue, Edison, NJ (FEI 2244819); inspected 03/16-03/27/2026, issued 09/17/2026, posted 09/29/2026
- DSRV take
- A CAPA that changes the limit and leaves the cause alone closes the record and keeps the risk. The file an inspector wants shows what caused the result, which other lots it reaches, and a limit change justified by data dated independently of the failure.
- 4 min readHigh exposurecited as a tag
A Quality Unit That Averaged Away Its Own OOS Failures
FDA's July 2026 warning letter to ABS Corporation shows a Quality Unit that averaged out failing assay results, handwrote higher specification limits onto batch records during validation, and released product made with a raw material that had already failed retesting. The pattern is not sloppy paperwork. It is a Quality Unit deciding the answer before the test ran.
- Case
- FDA Warning Letter CMS Case 732115 to ABS Corporation, July 23, 2026.
- DSRV take
- The decisive control is whether the quality system forces failing data to be investigated before specifications, retest logic, or batch disposition can be changed.
Pressure-test your evidence before an inspector reads it
Bring the document that has to hold up under 21 CFR 211.100(a). 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.