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);
(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.