§ 1271.170 Personnel

(a) General. You must have personnel sufficient to ensure compliance with the requirements of this part.

(b) Competent performance of functions. You must have personnel with the necessary education, experience, and training to ensure competent performance of their assigned functions. Personnel must perform only those activities for which they are qualified and authorized.

(c) Training. You must train all personnel, and retrain as necessary, to perform their assigned responsibilities adequately.

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 § 1271.170

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

• Trained or re-trained as necessary 19
• Qualifications lacking 10
• Not qualified, authorized for functions 5
• Sufficient number 1

FDA guidance that cites § 1271.170

• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
• 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

Amendment history

Federal Register documents that created or amended this section.

• 66 FR 5466 19 Jan 2001