---
kind: "section"
citation: "21 C.F.R. § 58.202"
title: "21"
number: "58.202"
heading: "Grounds for disqualification."
url: "https://uscodex.org/cfr/21/58.202"
---

# §58.202. Grounds for disqualification.


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.

## Notes

### Authority

Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.

### Source

Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.