21 CFR 820.72: Inspection, measuring, and test equipment
Required manufacturers to keep inspection, measuring, and test equipment suitable and accurate through documented calibration, maintenance, and storage procedures, using traceable standards, remedial action for out-of-limit results, and accessible calibration records.
Part 820, Quality System Regulation · Subpart G, Production and Process Controls
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.72, from the 483s we hold.
Procedures to ensure equipment is routinely calibrated have not been adequately established.Most used
Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.820.72(a)
Procedures to ensure equipment is routinely calibrated and maintained have not been adequately established.820.72(a)
Cited over time
483s citing 820.72, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 820.72
- Amigo Mobility International, Inc. · —Procedures to ensure that monitoring and measurement can be carried out and are… Feb 5, 2026
- RAC Medical Solutions · Bruceton, TennesseeProcedures to ensure equipment is routinely calibrated, inspected, checked and… Aug 7, 2025
- Ashland Specialty Ingredients, G.P · Bridgewater, New JerseyProcedures to ensure equipment is routinely calibrated and inspected have not been… Aug 7, 2025
- MAVIDON MEDICAL PRODUCTS · Flat Rock, North CarolinaProcedures to ensure equipment is routinely calibrated, inspected, checked and… Aug 5, 2025
- The Richline Group, Inc. · Tamarac, FloridaProcedures to ensure equipment is routinely calibrated, inspected, checked and… Apr 16, 2025
The regulation text
§ 820.72 Inspection, measuring, and test equipment. As published before it was replaced.
(a)Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b)Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.
(1)Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2)Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Questions
What does 21 CFR 820.72 require?
Required manufacturers to keep inspection, measuring, and test equipment suitable and accurate through documented calibration, maintenance, and storage procedures, using traceable standards, remedial action for out-of-limit results, and accessible calibration records.
How do FDA investigators word a 820.72 observation?
The most common opening is: “Procedures to ensure equipment is routinely calibrated have not been adequately established.”
Which sections are cited alongside 820.72?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.80 (Receiving, in-process, and finished device acceptance), 820.30 (Design controls).