21 CFR 211.89: Rejected components, drug product containers, and closures
Requires manufacturers to identify rejected components, drug product containers, and closures and hold them under a quarantine system that prevents their use in manufacturing or processing operations where they are unsuitable.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
How FDA words it
The opening lines investigators use most when they cite 211.89, from the 483s we hold.
Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.Most used
Recent 483s citing 211.89
- Cosmetic Essence, LLC dba Voyant Beauty · Roanoke, VirginiaRejected components and drug product containers are not controlled under a… Mar 28, 2025
- Summit Biosciences Inc. · Danbury, ConnecticutYour firm failed to identify and control rejected materials under a quarantine… Feb 21, 2025
- Saptalis Pharmaceuticals, LLC · Hauppauge, New YorkRejected drug product containers are not controlled under a quarantine system… Mar 17, 2023
- Regis Technologies Inc. · Morton Grove, Illinois2) Your Quality Unit failed to identify the rejected materials that were failed to… Nov 16, 2022
- Emergent Manufacturing Operations Baltimore LLC · Baltimore, MarylandSeparate or defmed areas to prevent contamination or mix-ups are deficient… Apr 20, 2020
The regulation text
§ 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.
Questions
What does 21 CFR 211.89 require?
Requires manufacturers to identify rejected components, drug product containers, and closures and hold them under a quarantine system that prevents their use in manufacturing or processing operations where they are unsuitable.
How do FDA investigators word a 211.89 observation?
The most common opening is: “Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.”
Which sections are cited alongside 211.89?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.68 (Automatic, mechanical, and electronic equipment), 211.192 (Production record review).