GroundRules
21 CFR 58.202: Grounds for disqualification.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER A—GENERAL
- PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- Subpart K—Disqualification of Testing Facilities
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON