§ 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.

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What FDA inspectors cite under § 211.65

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Equipment construction - reactive surfaces 50
• Substances That Come in Contact 5

Warning letters citing § 211.65

1 FDA warning letters since 2017 cite this section :

• Phillips Co. 8 May 2017

FDA guidance that cites § 211.65

• Establishing Impurity Specifications for Antibiotics draft 20 Apr 2026
• Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry draft 16 Dec 2021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for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
• Transdermal and Topical Delivery Systems - Product Development and Quality Considerations draft 21 Nov 2019
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004
• Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry 7 Jul 1999

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978