21 CFR 1271.250: Labeling controls
Requires HCT/P establishments to maintain labeling control procedures that ensure proper identification, prevent mix-ups, verify label accuracy, legibility and integrity, and ensure required labeling and donor eligibility documentation accompany each distributed product.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart D, Current Good Tissue Practice
Recent 483s citing 1271.250
- Americord Registry LLC · Somerset, New JerseyProcedures to control the labeling of HCT/Ps were not established, maintained,… Nov 17, 2025
- AVEM Labs LLC · —Labeling procedures did not include verification of label accuracy… May 21, 2025
- Musculoskeletal Transplant Foundation · Edison, New JerseyLabeling procedures were not designed to ensure proper HCTIP identi fication and t… May 19, 2014
- Osteotech, Inc. · Eatontown, New JerseyProcedures to control the labeling of HCT/Ps were not followed… Dec 13, 2010
The regulation text
§ 1271.250 Labeling controls.
(a)General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design these procedures to ensure proper HCT/P identification and to prevent mix-ups.
(b)Verification. Procedures must include verification of label accuracy, legibility, and integrity.
(c)Labeling requirements. Procedures must ensure that each HCT/P is labeled in accordance with all applicable labeling requirements, including those in §§ 1271.55, 1271.60, 1271.65, 1271.90, 1271.290, and 1271.370, and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under § 1271.55.
Questions
What does 21 CFR 1271.250 require?
Requires HCT/P establishments to maintain labeling control procedures that ensure proper identification, prevent mix-ups, verify label accuracy, legibility and integrity, and ensure required labeling and donor eligibility documentation accompany each distributed product.
Which sections are cited alongside 1271.250?
In the same 483s, investigators most often also cite 1271.160 (Establishment and maintenance of a quality program), 1271.180 (Procedures), 1271.195 (Environmental control and monitoring), 1271.200 (Equipment).