21 CFR 213.198
Complaint files
21 CFR 213.198 is the regulation titled “Complaint files” 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 213.198 most often, as written in the letters.
- 1 letterYour firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a medical gas, including provisions for review by the quality control unit of any…
The regulation
Read the text of 21 CFR 213.198 (eCFR, as of Sep 1, 2026)
(a) Written procedures shall be established and followed for the receipt and handling of all written or oral complaints concerning a medical gas. These procedures must include quality unit review of any complaint involving the possible failure of a medical gas to meet any of its specifications and provisions for determining the need for an investigation in accordance with § 213.192 as well as determining whether the complaint represents an event that is required to be reported to FDA under part 230 of this chapter. Any complaint involving a possible leak of a container or closure must be reviewed, evaluated, and investigated in accordance with § 213.192.
(b) A written record of each complaint regarding a medical gas must be maintained. The record must include the name of the gas, the lot or batch number, the name of the complainant, the date the complaint was received, the nature of the complaint, and the response to the complaint. It must also include the findings of any investigation and followup. Where an investigation is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.
(c) Complaint files shall be maintained in a manner such that they are readily available for inspection by the firm or by FDA during an inspection. Complaint files shall be maintained for at least 1 year after the date the complaint was received or for at least 3 years after distribution of the medical gas, whichever is longer.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 213.198.
- 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 213.22Responsibilities 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 213.198 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.