CFR section
21 CFR 1271.190(a): Facilities
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart D-Current Good Tissue Practice
Key facts
| Citation | 21 CFR 1271.190(a) |
|---|---|
| Section | Facilities |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart D-Current Good Tissue Practice |
| Subchapter | 21 CFR L Other |
| Product types cited | Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (a) General. Any facility used in the manufacture of HCT/Ps must be of suitable size, construction, and location to prevent contamination of HCT/Ps with communicable disease agents and to ensure orderly handling of HCT/Ps without mix-ups. You must maintain the facility in a good state of repair. You must provide lighting, ventilation, plumbing, drainage, and access to sinks and toilets that are adequate to prevent the introduction, transmission, or spread of communicable disease. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.