21 CFR 213.82
Receipt and storage of incoming designated medical gases
21 CFR 213.82 is the regulation titled “Receipt and storage of incoming designated medical gases” 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 213.82 most often, as written in the letters.
- 1 letterYour firm failed to test samples of each incoming designated medical gas for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and…
The regulation
Read the text of 21 CFR 213.82 (eCFR, as of Sep 1, 2026)
(a)(1) Upon receipt of each shipment of each incoming designated medical gas, the firm shall either perform full compendial testing on the gas and record the results or verify and record that a signed certificate of analysis from the supplier accompanies each different designated medical gas in a shipment. The certificate of analysis shall include the following:
(i) Supplier's name;
(ii) Name of the incoming designated medical gas;
(iii) Lot number or other unique identification number;
(iv) Actual analytical result obtained for strength, as well as the results of other tests performed;
(v) Identification of the test method(s) used for analysis;
(vi) New drug application and/or new animal drug application number of the incoming designated medical gas; and
(vii) Supplier representative's signature and the date of signature.
(2) If the incoming designated medical gas is obtained from a supplier other than the original manufacturer, the shipment shall also include complete information from the original manufacturer's certificate of analysis. The firm shall establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures.
(b) An identity test shall be performed upon receipt of the incoming designated medical gas.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 213.82.
- 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 213.22Responsibilities of quality unit1 letter cites both
Latest letters citing it
The letter citing 21 CFR 213.82 that FDA posted most recently.
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