shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.89 Rejected components, drug product containers, and closures
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 211.89
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Quarantine of Rejected Components et. al. 43
FDA guidance that cites § 211.89
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978