§ 211.89 Rejected components, drug product containers, and closures.
Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
How BatchGlow handles this
A lot is rejected by QA's signed decision and its stock is moved to the Rejected warehouse, where it cannot be used; while the lot has stock and no Rejected warehouse is set up, the decision is refused.
What it asks for, in plain words
- 21 CFR 211.89
- Rejected components, containers and closures are identified and kept under a quarantine system that prevents their use.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.