21 CFR 58.202
Grounds for disqualification
21 CFR 58.202 is the regulation titled “Grounds for disqualification” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 5 FDA warning letters have cited it.
- Letters citing it
- 5 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 58.33, in 5 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 58.202 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.202.
- 21 CFR 58.33Study director5 letters cite both
- 21 CFR 58.35Quality assurance unit5 letters cite both
- 21 CFR 58.81Standard operating procedures4 letters cite both
- 21 CFR 58.90Animal care4 letters cite both
- 21 CFR 58.31Testing facility management3 letters cite both
- 21 CFR 58.130Conduct of a nonclinical laboratory study2 letters cite both
- 21 CFR 58.185Reporting of nonclinical laboratory study results2 letters cite both
- 21 CFR 58.107Test and control article handling1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 58.202 that FDA posted most recently.
- DevicesView Palamur Biosciences Private Limitednonclinical laboratory studies for medical devicesIssuedDec 11, 2025PostedDec 30, 2025
- DevicesView Jiangsu Kerbio Medical Technology Group Co.nonclinical laboratory testing services for medical devicesIssuedJul 11, 2025PostedAug 26, 2025
- DevicesView CCIC Huatongwei International Inspection Co., Ltd.GLP nonclinical safety testing for medical devicesIssuedJun 25, 2025PostedAug 26, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.