21 CFR 58.31
Testing facility management
21 CFR 58.31 is the regulation titled “Testing facility management” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 58.35, in 4 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (3 of 4). 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 58.31 most often, as written in the letters.
- 1 letterFailure of the testing facility management to assure that personnel clearly understand the functions they are to perform [21 CFR 58.31(f)]
- 1 letterFailure of the testing facility management to assure that tests for mixtures of articles with carriers were conducted by appropriate analytical methods to determine the uniformity of the mixture and the concentration of…
- 1 letterFailure of the testing facility management to assure the availability of equipment as scheduled and that the equipment used in the generation, measurement, or assessment of data shall be of appropriate design and…
The regulation
Read the text of 21 CFR 58.31 (eCFR, as of Sep 1, 2026)
For each nonclinical laboratory study, testing facility management shall:
(a) Designate a study director as described in § 58.33, before the study is initiated.
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in § 58.35.
(d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are to perform.
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.31.
- 21 CFR 58.35Quality assurance unit4 letters cite both
- 21 CFR 58.81Standard operating procedures4 letters cite both
- 21 CFR 58.202Grounds for disqualification3 letters cite both
- 21 CFR 58.33Study director3 letters cite both
- 21 CFR 58.90Animal care2 letters cite both
- 21 CFR 58.113Mixtures of articles with carriers1 letter cites both
- 21 CFR 58.130Conduct of a nonclinical laboratory study1 letter cites both
- 21 CFR 58.185Reporting of nonclinical laboratory study results1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 58.31 that FDA posted most recently.
- DrugsView HealthPartners Neuroscience Center Research and Innovationinvestigational drug (b)(4)IssuedMay 19, 2026PostedJun 2, 2026
- DevicesView Palamur Biosciences Private Limitednonclinical laboratory studies for medical devicesIssuedDec 11, 2025PostedDec 30, 2025
- DevicesView Mid-Link Testing Company, Ltdnonclinical laboratory studies for medical devicesIssuedSep 10, 2024PostedSep 11, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.