21 C.F.R. · Food and Drugs
21 C.F.R. § 58.202

Grounds for disqualification.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 58.202 — Grounds for disqualification.

§ 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.

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21 C.F.R. § 58.202
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The regulatory text of 21 C.F.R. § 58.202 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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