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Code · CFR · Title 21 — Food and Drugs · Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies · § 58.202

§ 58.202. Grounds for disqualification.

85 words·~1 min read·/us/cfr/t21/s§ 58.202·

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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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