CFR section
21 CFR 820.72(b)(2): Inspection, measuring, and test equipment
PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls
Key facts
| Citation | 21 CFR 820.72(b)(2) |
|---|---|
| Section | Inspection, measuring, and test equipment |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart G-Production and Process Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (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. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.