21 C.F.R. § 213.184

Current through September 30, 2024
Section 213.184 - [Effective 12/18/2025] Records for components, medical gas containers and closures, and labeling

Records for components, medical gas containers and closures, and labeling shall include the following:

(a) The results of any test or examination performed (including those performed as required by § 213.84 or § 213.122) and the conclusions derived therefrom.
(b) Documentation of the examination and review of labels and labeling for conformity with established specifications in accordance with §§ 213.122 and 213.130.
(c) The disposition of rejected components, medical gas containers and closures, and labeling.

21 C.F.R. §213.184

89 FR 51770, 12/18/2025