21 CFR 211.63
Equipment design, size, and location
21 CFR 211.63 is the regulation titled “Equipment design, size, and location” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 25 FDA warning letters have cited it.
- Letters citing it
- 25 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 5 on the same dates in 2025
- Most often cited with
- 21 CFR 211.192, in 12 letters
- Closed out
- 4% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (23 of 25). 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 211.63 most often, as written in the letters.
- 17 lettersYour firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and…
- 1 letterYour firm failed to ensure container closure systems provide protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product (21 CFR 211.94(b))
- 1 letterYour firm 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))
The regulation
Read the text of 21 CFR 211.63 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.63.
- 21 CFR 211.192Production record review12 letters cite both
- 21 CFR 211.100Written procedures; deviations9 letters cite both
- 21 CFR 211.113Control of microbiological contamination9 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit9 letters cite both
- 21 CFR 211.166Stability testing8 letters cite both
- 21 CFR 201.128Meaning of “intended uses”7 letters cite both
- 21 CFR 211.165Testing and release for distribution7 letters cite both
- 21 CFR 211.42Design and construction features7 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.63 that FDA posted most recently.
- DrugsView Rohto Pharmaceutical Co., Ltd.Over-the-counter topical ophthalmic drug products manufactured using aseptic processing.IssuedOct 14, 2026PostedOct 20, 2026
- DrugsView PReye, LLCPReye Vitamin SEEIssuedAug 18, 2026PostedSep 1, 2026
- DrugsView International Medication Systems LimitedActive pharmaceutical ingredients and sterile injectable drug productsIssuedJul 2, 2026PostedJul 14, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.