21 CFR 1271.210
Supplies and reagents
21 CFR 1271.210 is the regulation titled “Supplies and reagents” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.180, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 1271.210 (eCFR, as of Sep 1, 2026)
(a) Verification. You must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent.
(b) Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate.
(c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents.
(d) Records. You must maintain the following records pertaining to supplies and reagents:
(1) Records of the receipt of each supply or reagent, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date;
(2) Records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a certificate of analysis from the vendor; and
(3) Records of the lot of supply or reagent used in the manufacture of each HCT/P.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.210.
- 21 CFR 1271.180Procedures1 letter cites both
- 21 CFR 1271.190Facilities1 letter cites both
- 21 CFR 1271.195Environmental control and monitoring1 letter cites both
- 21 CFR 1271.200Equipment1 letter cites both
- 21 CFR 1271.215Recovery1 letter cites both
- 21 CFR 1271.220Processing and process controls1 letter cites both
- 21 CFR 1271.230Process validation1 letter cites both
- 21 CFR 1271.250Labeling controls1 letter cites both
Latest letters citing it
The letter citing 21 CFR 1271.210 that FDA posted most recently.
See the letter citing 21 CFR 1271.210 →Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.