US FDA
21 CFR 211.89 - Rejected Components, Containers and Closures
Plain-language explanation, inspection context and common violation patterns.
What it says
Rejected components, drug product containers and closures must be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Rejected material should be clearly labeled and physically or systematically separated from usable stock.
- Electronic status controls can serve as the quarantine, if they genuinely prevent use of rejected material.
- Disposition, whether return to supplier or destruction, should be tracked until the material leaves the site.
What FDA inspectors look for
- Whether rejected material is clearly identified and segregated.
- Whether system controls would block use of rejected material.
- Whether disposition of rejected lots is documented.
Most common violation
Rejected material stored in the same location as released stock with only a handwritten tag to distinguish it.
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