§ 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 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 1271.250

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Human Tissue for Transplantation).

• Controlling the labeling of HCT/Ps 13
• All labeling requirements met 5
• Verification of label accuracy, legibility, integrity 4
• Design of labeling procedures 2
• Documentation of donor eligibility 1

Warning letters citing § 1271.250

1 FDA warning letters since 2017 cite this section :

• Utah Cord Bank LLC 11 May 2021

FDA guidance that cites § 1271.250

• Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry 6 Sept 2017
• Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry 8 Mar 2016
• Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry 1 Dec 2011
• Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors 1 Apr 2008

Amendment history

Federal Register documents that created or amended this section.

• 66 FR 5466 19 Jan 2001