21 CFR 110.40: Equipment and utensils
Requires food plant equipment and utensils to be cleanable, properly maintained, and built to prevent contamination, with sanitary food-contact surfaces, temperature monitoring in cold storage, accurate control instruments, and uncontaminated compressed air or gases.
Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food · Subpart C, Equipment
How FDA words it
The opening lines investigators use most when they cite 110.40, from the 483s we hold.
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth ofmicroorganisms.Most used
Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.110.40(a)
Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained.110.40(f)
Recent 483s citing 110.40
- Chamberlain Farms Inc. · Owensville, IndianaFood contact surfaces are not constructed/designed in a manner to allow for… Aug 14, 2020
- Vulto Creamery LLC · Walton, New YorkThe design and materials of equipment does not allow proper cleaning and… Mar 22, 2017
- The Aloe Source · Plano, TexasFailure to have smoothly bonded or well maintained seams on food contact surfaces,… May 20, 2016
- Jeni's Splendid Ice Creams, LLC · Columbus, OhioNon food-contact equipment in manufacturing and food handling areas is not… Apr 30, 2015
- Blue Bell Creameries Inc, · Sylacauga, AlabamaFailure to maintain food contact surfaces to protect food from contamination by any… Apr 30, 2015
The regulation text
§ 110.40 Equipment and utensils.
(a)All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.
(b)Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.
(c)Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.
(d)Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.
(e)Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.
(f)Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses.
(g)Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.
Questions
What does 21 CFR 110.40 require?
Requires food plant equipment and utensils to be cleanable, properly maintained, and built to prevent contamination, with sanitary food-contact surfaces, temperature monitoring in cold storage, accurate control instruments, and uncontaminated compressed air or gases.
How do FDA investigators word a 110.40 observation?
The most common opening is: “Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth ofmicroorganisms.”
Which sections are cited alongside 110.40?
In the same 483s, investigators most often also cite 110.80 (Processes and controls), 110.20 (Plant and grounds), 110.35 (Sanitary operations), 110.10 (Personnel).