§58.202. Grounds for disqualification.
21 C.F.R. § 58.202
The Commissioner may disqualify a testing facility upon finding all of the following:
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);
The noncompliance adversely affected the validity of the nonclinical laboratory studies; and
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, amendments, and revision history
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.