21 CFR 58.29
Personnel
21 CFR 58.29 is the regulation titled “Personnel” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 58.185, in 2 letters
- Closed out
- 50% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (1 of 2). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 58.29 most often, as written in the letters.
- 1 letterFailure to ensure that each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have the education, training, and experience, or combination thereof, to enable that…
The regulation
Read the text of 21 CFR 58.29 (eCFR, as of Sep 1, 2026)
(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.
(e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.29.
- 21 CFR 58.185Reporting of nonclinical laboratory study results2 letters cite both
- 21 CFR 58.33Study director2 letters cite both
- 21 CFR 58.35Quality assurance unit2 letters cite both
- 21 CFR 58.120Protocol1 letter cites both
- 21 CFR 58.130Conduct of a nonclinical laboratory study1 letter cites both
- 21 CFR 58.190Storage and retrieval of records and data1 letter cites both
- 21 CFR 58.202Grounds for disqualification1 letter cites both
- 21 CFR 58.31Testing facility management1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 58.29 that FDA posted most recently.
- DevicesView Sanitation & Environmental Technology Institute dba SDWHGLP nonclinical biocompatibility testing services for medical devicesIssuedSep 10, 2024PostedSep 11, 2024
- BiologicsView Valley BiosystemsNonclinical GLP studies for investigational productsIssuedAug 3, 2022PostedAug 9, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.