21 CFR 213.192
Production record review
21 CFR 213.192 is the regulation titled “Production record review” 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 213.192 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 213.192 (eCFR, as of Sep 1, 2026)
(a) Manufacturing production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality unit to determine compliance with all established, approved written procedures before a batch is released or distributed. The quality unit must review production records to determine whether errors or unexplained discrepancies have occurred prior to batch release. If errors or unexplained discrepancies have occurred, or a batch or any component of the batch fails to meet any of its specifications, the firm must thoroughly investigate and take appropriate corrective actions. A written record of the investigation shall be made and shall include the conclusions and followup.
(b) For production and control records of filling at a delivery site, quality unit review as described in paragraph (a) of this section shall be within one business day after fill.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 213.192.
- 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 213.198Complaint 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 213.192 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.