Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.58 Maintenance
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 211.58
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Buildings not maintained in good state of repair 319
Warning letters citing § 211.58
20 FDA warning letters since 2017 cite this section ; the most recent:
- Jabil Inc. 27 Aug 2026
- Fagron BV 12 May 2026
- Patcos Cosmetics Pvt. Ltd. 12 Mar 2026
- Winder Laboratories, LLC 7 Jan 2026
- Rechon Life Science AB 30 Apr 2025
- Granules India Limited 26 Feb 2025
- Colgate-Palmolive/Tom's of Maine, Inc. 5 Nov 2024
- Kaylaan LLC 19 Aug 2024
- C&T Dream Co., Ltd. 11 Apr 2024
- Fresenius Kabi AG 14 Sept 2023
- New England Life Care, Inc. dba Advanced Compounding Solutions 16 May 2023
- Drivergent, Inc. 1 May 2023
FDA guidance that cites § 211.58
- Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry draft 16 Dec 2021
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978