Code of Federal Regulations · Section
§ 213.89 — Rejected Components, Incoming Designated Medical Gases, And Medical Gas Containers And Closures
21 C.F.R. § 213.89
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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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321