21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies

§ 58.202 Grounds for disqualification

Subpart K - Disqualification of Testing Facilities Official text on eCFR Amendment history

The Commissioner may disqualify a testing facility upon finding all of the following:

(a) The testing facility failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter);

(b) The noncompliance adversely affected the validity of the nonclinical laboratory studies; and

(c) Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not been or will probably not be adequate to achieve compliance with the good laboratory practice regulations.

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Warning letters citing § 58.202

8 FDA warning letters since 2017 cite this section :

Amendment history

Federal Register documents that created or amended this section.