21 CFR 213.165
Testing and release for distribution
21 CFR 213.165 is the regulation titled “Testing and release for distribution” 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
What FDA writes when it cites it
The finding headings that cite 21 CFR 213.165 most often, as written in the letters.
- 1 letterYour firm failed to have, for each batch of medical gas, appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength of each active…
The regulation
Read the text of 21 CFR 213.165 (eCFR, as of Sep 1, 2026)
(a) For each batch of medical gas, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength, prior to release.
(b) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling, the number of units per batch to be tested, and acceptance criteria. Such written procedures shall be followed.
(c) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 213.194(a)(2). The suitability of all testing methods shall be verified under actual conditions of use.
(d) Medical gases failing to meet established standards or specifications and any other relevant quality criteria shall be rejected.
(e) This section does not apply to the filling of a designated medical gas or medically appropriate combination of designated medical gases via liquid to liquid into a container at a delivery site.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 213.165.
- 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 213.192Production record review1 letter cites both
- 21 CFR 213.198Complaint files1 letter cites both
- 21 CFR 213.22Responsibilities of quality unit1 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 213.165 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.