Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.63 Equipment design, size, and location
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 § 211.63
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Equipment Design, Size and Location 697
Warning letters citing § 211.63
51 FDA warning letters since 2017 cite this section ; the most recent:
- Rohto Pharmaceutical Co., Ltd. 14 Oct 2026
- PReye, LLC 18 Aug 2026
- International Medication Systems Limited 2 Jul 2026
- Fareva Amboise 10 Apr 2026
- Fareva Morton Grove 3 Mar 2026
- Cosmetic Manufacturers Pty Ltd. 6 Feb 2026
- Bio-Medical Pharmaceutical Manufacturing Corporation 5 Feb 2026
- SV Labs Corporation 9 Dec 2025
- Wells Pharma of Houston, LLC 7 Nov 2025
- World Perfumes Inc. 29 Oct 2025
- Liebel-Flarsheim Company LLC 17 Oct 2025
- Acme United Corporation 10 Oct 2025
FDA guidance that cites § 211.63
- Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry draft 16 Dec 2021
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry draft 29 Sept 2021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for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry 13 Dec 2018
- 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
- Process Validation: General Principles and Practices: Guidance for Industry 25 Jan 2011
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978