21 CFR 211.58
Maintenance
21 CFR 211.58 is the regulation titled “Maintenance” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 13 FDA warning letters have cited it.
- Letters citing it
- 13 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 211.192, in 7 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (12 of 13). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.58 most often, as written in the letters.
- 9 lettersYour firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58)
- 1 letterYou failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v))
- 1 letterYou failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58)
The regulation
Read the text of 21 CFR 211.58 (eCFR, as of Sep 1, 2026)
Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.58.
- 21 CFR 211.192Production record review7 letters cite both
- 21 CFR 211.113Control of microbiological contamination6 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit6 letters cite both
- 21 CFR 211.100Written procedures; deviations5 letters cite both
- 21 CFR 211.188Batch production and control records4 letters cite both
- 21 CFR 211.42Design and construction features4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4 letters cite both
- 21 CFR 211.160General requirements3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.58 that FDA posted most recently.
- DrugsView Jabil Inc.Contract manufacturer of sterile injectablesIssuedAug 27, 2026PostedSep 1, 2026
- DrugsView Fagron BVsterile compounded drug productsIssuedMay 12, 2026PostedJun 9, 2026
- DrugsView Patcos Cosmetics Pvt. Ltd.OTC drug products manufactured at a contract facilityIssuedMar 12, 2026PostedMar 17, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.