21 CFR 58.190
Storage and retrieval of records and data
21 CFR 58.190 is the regulation titled “Storage and retrieval of records and data” 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 1 on the same dates in 2025
- Most often cited with
- 21 CFR 58.130, 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 58.190 most often, as written in the letters.
- 1 letterFailure to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens and interim and final reports [21 CFR 58.190(b)]
The regulation
Read the text of 21 CFR 58.190 (eCFR, as of Sep 1, 2026)
(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
(c) An individual shall be identified as responsible for the archives.
(d) Only authorized personnel shall enter the archives.
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.190.
- 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 58.33Study director2 letters cite both
- 21 CFR 58.35Quality assurance unit2 letters cite both
- 21 CFR 58.120Protocol1 letter cites both
- 21 CFR 58.202Grounds for disqualification1 letter cites both
- 21 CFR 58.29Personnel1 letter cites both
- 21 CFR 58.51Specimen and data storage facilities1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 58.190 that FDA posted most recently.
- DevicesView CCIC Huatongwei International Inspection Co., Ltd.GLP nonclinical safety testing for medical devicesIssuedJun 25, 2025PostedAug 26, 2025
- 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.