Corrective and Preventive Action, 21 C.F.R. § 820.100

U.S. Food and Drug Administration. (2012). Corrective and Preventive Action, 21 C.F.R. § 820.100. Code of Federal Regulations, 8.

Type

Journal article

Intellectual base

Primary research

Year

2012

Link

https://www.govinfo.gov/content/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-sec820-100.pdf

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Mechanisms

• Exception Review Workflow
  • The guard is the review trigger — waivers are counted, and a band that keeps needing them is fixed, not perpetually excused.

    This sourceRequires concessions and quality data to be analyzed for recurring problems and those problems to receive corrective and preventive action.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:27cd0d5d5fcf · see in the full table