21 CFR 1271.170: Personnel
Requires HCT/P establishments to maintain enough personnel with the education, experience, and training to perform their assigned functions competently, limit staff to qualified and authorized activities, and train or retrain them as needed.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart D, Current Good Tissue Practice
How FDA words it
The opening lines investigators use most when they cite 1271.170, from the 483s we hold.
The quality program has not ensured the proper training and education of personnel involved in core GTP activities.Most used
Recent 483s citing 1271.170
- Donor Alliance, Inc. · Denver, ColoradoThe quality program has not ensured the proper training and education of personnel… Jan 15, 2026
- Musculoskeletal Transplant Foundation · Syracuse, New YorkThe quality program has not ensured the proper training and education of personnel… Oct 26, 2006
- LifeCell Corporation · Somerville, New JerseyThe quality program has not ensured the proper training and education of personnel… Sep 27, 2006
The regulation text
§ 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.
Questions
What does 21 CFR 1271.170 require?
Requires HCT/P establishments to maintain enough personnel with the education, experience, and training to perform their assigned functions competently, limit staff to qualified and authorized activities, and train or retrain them as needed.
How do FDA investigators word a 1271.170 observation?
The most common opening is: “The quality program has not ensured the proper training and education of personnel involved in core GTP activities.”
Which sections are cited alongside 1271.170?
In the same 483s, investigators most often also cite 1271.160 (Establishment and maintenance of a quality program), 1271.75 (How do I screen a donor?), 1271.190 (Facilities), 1271.200 (Equipment).