21 CFR 58.107
Test and control article handling
21 CFR 58.107 is the regulation titled “Test and control article handling” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 58.202, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 58.107 most often, as written in the letters.
- 1 letterFailure to establish procedures for a system for the handling of the test and control articles to ensure that (1) proper identification is maintained throughout the distribution process and (2) the receipt and…
The regulation
Read the text of 21 CFR 58.107 (eCFR, as of Sep 1, 2026)
Procedures shall be established for a system for the handling of the test and control articles to ensure that:
(a) There is proper storage.
(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
(c) Proper identification is maintained throughout the distribution process.
(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.107.
- 21 CFR 58.202Grounds for disqualification1 letter cites both
- 21 CFR 58.33Study director1 letter cites both
- 21 CFR 58.35Quality assurance unit1 letter cites both
- 21 CFR 58.43Animal care facilities1 letter cites both
- 21 CFR 58.49Laboratory operation areas1 letter cites both
- 21 CFR 58.81Standard operating procedures1 letter cites both
- 21 CFR 58.90Animal care1 letter cites both
Latest letters citing it
The letter citing 21 CFR 58.107 that FDA posted most recently.
See the letter citing 21 CFR 58.107 →Put this kind of reading to
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Counts include every citation in a letter, as the Letters filter does. How this database is built.