21 CFR 1271.180
Procedures
21 CFR 1271.180 is the regulation titled “Procedures” 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 1271.190, 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
What FDA writes when it cites it
The finding headings that cite 21 CFR 1271.180 most often, as written in the letters.
- 1 letterFailure to establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that…
The regulation
Read the text of 21 CFR 1271.180 (eCFR, as of Sep 1, 2026)
(a) General. You must establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of HCT/Ps.
(b) Review and approval. Before implementation, a responsible person must review and approve these procedures.
(c) Availability. These procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.
(d) Standard procedures. If you adopt current standard procedures from another organization, you must verify that the procedures meet the requirements of this part and are appropriate for your operations.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.180.
- 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 1271.210Supplies and reagents1 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 1271.180 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.