21 CFR 213.22
Responsibilities of quality unit
21 CFR 213.22 is the regulation titled “Responsibilities of quality unit” in 21 CFR Part 213, Current Good Manufacturing Practice for Medical Gases. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.165, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
The regulation
Read the text of 21 CFR 213.22 (eCFR, as of Sep 1, 2026)
(a) There shall be a quality unit that shall have the responsibility and authority to approve or reject all components, medical gas containers and closures, in-process materials, packaging material, labeling, and medical gases, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality unit shall be responsible for approving or rejecting medical gases manufactured, processed, packed, or held under contract by another company.
(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, medical gas containers and closures, packaging materials, in-process materials, and medical gases shall be available to the quality unit.
(c) The quality unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the medical gas.
(d) The responsibilities and procedures applicable to the quality unit shall be in writing; such written procedures shall be followed.
(e) Quality unit personnel may perform other functions provided appropriate written controls are in place to ensure any other functions are performed separately from quality unit responsibilities and such other functions do not interfere with the quality unit's responsibilities or subordinate the quality unit's responsibilities to any other unit.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 213.22.
- 21 CFR 211.165Testing and release for distribution1 letter cites both
- 21 CFR 211.198Complaint files1 letter cites both
- 21 CFR 211.22Responsibilities of quality control unit1 letter cites both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1 letter cites both
- 21 CFR 213.165Testing and release for distribution1 letter cites both
- 21 CFR 213.192Production record review1 letter cites both
- 21 CFR 213.198Complaint files1 letter cites both
- 21 CFR 213.82Receipt and storage of incoming designated medical gases1 letter cites both
Latest letters citing it
The letter citing 21 CFR 213.22 that FDA posted most recently.
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