GroundRules
21 CFR 213.89: Rejected components, incoming designated medical gases, and medical gas containers and closures.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER C—DRUGS: GENERAL
- PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
- Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures
Rejected components, incoming designated medical gases, and medical gas 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 and shall be documented and assessed.
Collected 2026-08-27T02:24:47Z. Source file · JSON