C.F.R. » Title 21 » 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

21 C.F.R. § 213.89

Rejected components, incoming designated medical gases, and medical gas containers and closures

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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.