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.
21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies
§ 58.61 Equipment design
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Warning letters citing § 58.61
1 FDA warning letters since 2017 cite this section :
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 33780 4 Sept 1987