21 CFR 58.185
Reporting of nonclinical laboratory study results
21 CFR 58.185 is the regulation titled “Reporting of nonclinical laboratory study results” 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
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 58.33, in 5 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (2 of 5). 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 58.185 most often, as written in the letters.
- 1 letterFailure to prepare final reports that were signed and dated by each of the individual scientists or other professionals involved in the studies [21 CFR 58.185(a)(12)]
- 1 letterYou failed to prepare a final report for each nonclinical laboratory study that includes, but is not limited to, the following: (1) name and address of the testing facility; (2) name of the study director and other…
The regulation
Read the text of 21 CFR 58.185 (eCFR, as of Sep 1, 2026)
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:
(1) Name and address of the facility performing the study and the dates on which the study was initiated and completed.
(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(3) Statistical methods employed for analyzing the data.
(4) The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics.
(5) Stability of the test and control articles under the conditions of administration.
(6) A description of the methods used.
(7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
(8) A description of the dosage, dosage regimen, route of administration, and duration.
(9) A description of all circumstances that may have affected the quality or integrity of the data.
(10) The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.
(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study.
(13) The locations where all specimens, raw data, and the final report are to be stored.
(14) The statement prepared and signed by the quality assurance unit as described in § 58.35(b)(7).
(b) The final report shall be signed and dated by the study director.
(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.185.
- 21 CFR 58.33Study director5 letters cite both
- 21 CFR 58.35Quality assurance unit4 letters cite both
- 21 CFR 58.130Conduct of a nonclinical laboratory study2 letters cite both
- 21 CFR 58.190Storage and retrieval of records and data2 letters cite both
- 21 CFR 58.202Grounds for disqualification2 letters cite both
- 21 CFR 58.29Personnel2 letters cite both
- 21 CFR 58.81Standard operating procedures2 letters cite both
- 21 CFR 58.90Animal care2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 58.185 that FDA posted most recently.
- DrugsView Vedic Lifesciences Pvt. Ltd.investigational drug (b)(4)IssuedMar 9, 2026PostedMar 17, 2026
- DevicesView CCIC Huatongwei International Inspection Co., Ltd.GLP nonclinical safety testing for medical devicesIssuedJun 25, 2025PostedAug 26, 2025
- DevicesView Sanitation & Environmental Technology Institute dba SDWHGLP nonclinical biocompatibility testing services 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.