21 CFR 1271.180: Procedures
Requires HCT/P manufacturers to establish, maintain, and have a responsible person approve procedures for all manufacturing steps that prevent communicable disease transmission, keep them accessible where work occurs, and verify any adopted standard procedures.
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 1271.180, from the 483s we hold.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.Most used
Recent 483s citing 1271.180
- Americord Registry LLC · Somerset, New JerseyProcedures appropriate to meet core CGTP requirements for all steps that you… Nov 17, 2025
- Musculoskeletal Transplant Foundation · Edison, New JerseyProcedures appropriate to meet core CGTP requirements for all steps that you… May 19, 2014
- Osteotech, Inc. · Eatontown, New JerseyProcedures appropriate to meet core CGTP requirements for all steps that you… Dec 13, 2010
- Osteotech, Inc · Shrewsbury, New JerseyProcedures were not designed to prevent circumstances that increase the risk of… Dec 9, 2010
- DePuy Sa n Antonio · San Antonio, TexasProcedures appropriate to meet core CGTP requirements for all steps that you… Oct 28, 2009
The regulation text
§ 1271.180 Procedures.
(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.
Questions
What does 21 CFR 1271.180 require?
Requires HCT/P manufacturers to establish, maintain, and have a responsible person approve procedures for all manufacturing steps that prevent communicable disease transmission, keep them accessible where work occurs, and verify any adopted standard procedures.
How do FDA investigators word a 1271.180 observation?
The most common opening is: “Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.”
Which sections are cited alongside 1271.180?
In the same 483s, investigators most often also cite 1271.160 (Establishment and maintenance of a quality program), 1271.250 (Labeling controls), 1271.190 (Facilities), 1271.195 (Environmental control and monitoring).