21 CFR 211.58 - Maintenance

What it says

Buildings used in the manufacture, processing, packing or holding of drug products must be maintained in good repair, addressing structural elements such as floors, walls and ceilings to prevent conditions that could lead to product contamination or mix-up.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision addresses the physical condition of the facility itself, distinct from equipment maintenance under 211.67, covering structural elements like flooring, wall surfaces and ceiling integrity.
• Deferred maintenance that seems purely cosmetic, such as a cracked wall surface or damaged flooring, can become a genuine contamination control issue if it creates a surface that is difficult to clean or a point where contaminants can accumulate.
• A preventive maintenance approach to facility upkeep is expected, rather than addressing structural issues reactively only after they become severe enough to be obviously problematic.

What FDA inspectors look for

• Whether visible facility condition, floors, walls, ceilings, matches what would be expected for the classification and use of that specific area.
• Whether a documented facility maintenance programme exists and shows evidence of being followed, not just reactive repairs after visible deterioration.
• Whether damaged surfaces in areas near open product or critical processing are prioritised for repair given the elevated contamination risk they present.

Related regulations