CFR section

21 CFR 58.61: Equipment design

PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart D-Equipment

Key facts

Citation 21 CFR 58.61
Section Equipment design
Part PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart Subpart D-Equipment
Subchapter 21 CFR A General
Product types cited General, Veterinary
Regulation text (excerpt) Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance.

At a glance

  • 10–99 Inspections citing this section
  • 1–9 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA