Regulation Text
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.
Authority
21 U.S.C. 321,351,352,353,355,360b,360ddd,360ddd-1,371,374.