§ 213.184 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.