21 CFR 211.58: Maintenance
Requires that any building used to manufacture, process, pack, or hold a drug product be kept in a good state of repair.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart C, Buildings and Facilities
5%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.58, from the 483s we hold.
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.Most used
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
Cited over time
483s citing 211.58, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 211.58
- QuVa Pharma, Inc · Sugar Land, TexasBuildings used in the manufacturing, processing, packing and holding of a drug… May 4, 2026
- Nice-Pak Products, LLC One Nice-Pak Rd · Mooresville, IndianaBuildings used in the manufacturing of a drug product are not maintained in a good… Apr 20, 2026
- Pharmaneek Inc. · Ind ianapolis, IndianaYour fac.ility is not maintained in a good state of repair, creating insanitaiy… Apr 8, 2026
- Granules Pharmaceuticals Inc. · Chantilly, VirginiaBuildings used in the holding of a drug product are not maintained in a good state… Apr 3, 2026
- Ve t erinary Pharmacy Corporation · Saint Peter, MinnesotaContamination was observed in your production area and areas adjacent to production… Mar 19, 2026
The regulation text
§ 211.58 Maintenance.
Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.
Questions
What does 21 CFR 211.58 require?
Requires that any building used to manufacture, process, pack, or hold a drug product be kept in a good state of repair.
How often is 211.58 cited in Form 483s?
It appears in about 5% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.58 observation?
The most common opening is: “Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.”
Which sections are cited alongside 211.58?
In the same 483s, investigators most often also cite 211.67 (Equipment cleaning and maintenance), 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.100 (Written procedures; deviations).