21 CFR 213.184
§ 213.184 Records for components, medical gas containers and closures, and labeling.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 213.184, § 213.184 Records for components, medical gas containers and closures, and labeling, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86068
- Permanent ID
ys:prov:86068@1- SHA-256
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Full 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.