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.
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