21 CFR 211.65: Equipment construction
Requires equipment product-contact surfaces to be non-reactive, non-additive, and non-absorptive, and operating substances like lubricants or coolants must not contact materials or products in ways that alter drug safety, identity, strength, quality, or purity.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart D, Equipment
How FDA words it
The opening lines investigators use most when they cite 211.65, from the 483s we hold.
Equipment surfaces that contact components are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.Most used
Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.211.65(a)
Cited over time
483s citing 211.65, by yearMost citations in 2017. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2017.
Recent 483s citing 211.65
- Linde Industrial Gas · La Porte, IndianaEquipment shall be constructed so that surfaces that contact components, in-process… Mar 11, 2026
- Pyramid Laboratories, Inc · Costa Mesa, CaliforniaEquipment surf;ices that contact components and in-prc>cess mate•rials are… Feb 13, 2026
- Dabur India Limited · Dadra And Nagar Haveli, IndiaEquipment surfaces that contact components and in-process materials are reactive,… Jan 16, 2026
- Park Avenue Compounding · Saint Louis, MissouriEquipment surfaces that contact components, in-process materials and drug products… Sep 23, 2025
- Particle Dynamics · Seymour, IndianaFailure to ensure that equipment surfaces in contact with intermediates and active… Apr 14, 2025
The regulation text
§ 211.65 Equipment construction.
(a)Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b)Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
Questions
What does 21 CFR 211.65 require?
Requires equipment product-contact surfaces to be non-reactive, non-additive, and non-absorptive, and operating substances like lubricants or coolants must not contact materials or products in ways that alter drug safety, identity, strength, quality, or purity.
How do FDA investigators word a 211.65 observation?
The most common opening is: “Equipment surfaces that contact components are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
Which sections are cited alongside 211.65?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance), 211.113 (Control of microbiological contamination).