GroundRules
21 CFR 213.184: Records for components, medical gas containers and closures, and labeling.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER C—DRUGS: GENERAL
- PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
- Subpart J—Records
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON