21 CFR 211.42
Design and construction features
21 CFR 211.42 is the regulation titled “Design and construction features” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 98 FDA warning letters have cited it.
- Letters citing it
- 98 since 2021
- Jan 1 to Oct 30, 2026
- 27 against 20 on the same dates in 2025
- Most often cited with
- 21 CFR 211.113, in 73 letters
- Closed out
- 7% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (79 of 98). 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 211.42 most often, as written in the letters.
- 21 lettersYour firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv))
- 16 lettersYour firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic…
- 10 lettersYour 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 211.42 (eCFR, as of Sep 1, 2026)
(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.
(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.
(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures:
(1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;
(2) Holding rejected components, drug product containers, closures, and labeling before disposition;
(3) Storage of released components, drug product containers, closures, and labeling;
(4) Storage of in-process materials;
(5) Manufacturing and processing operations;
(6) Packaging and labeling operations;
(7) Quarantine storage before release of drug products;
(8) Storage of drug products after release;
(9) Control and laboratory operations;
(10) Aseptic processing, which includes as appropriate:
(i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;
(ii) Temperature and humidity controls;
(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar;
(iv) A system for monitoring environmental conditions;
(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
(vi) A system for maintaining any equipment used to control the aseptic conditions.
(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.
[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.42.
- 21 CFR 211.113Control of microbiological contamination73 letters cite both
- 21 CFR 211.192Production record review58 letters cite both
- 21 CFR 211.100Written procedures; deviations40 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit35 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers28 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations28 letters cite both
- 21 CFR 211.160General requirements28 letters cite both
- 21 CFR 211.166Stability testing25 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.42 that FDA posted most recently.
- DrugsView Baxter International Inc.Sterile injectable drugs, including cephalosporins and other productsIssuedSep 29, 2026PostedOct 20, 2026
- DrugsView Hanlim Pharm Co., Ltd.sterile (b)(4) drug productsIssuedOct 2, 2026PostedOct 13, 2026
- DrugsView SCA Pharmaceuticals, LLCCompounded sterile drug productsIssuedSep 14, 2026PostedOct 13, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.