CFR section
21 CFR 1271.160(b)(3): Establishment and maintenance of a quality program
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart D-Current Good Tissue Practice
Key facts
| Citation | 21 CFR 1271.160(b)(3) |
|---|---|
| Section | Establishment and maintenance of a quality program |
| 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, Other_Regulations |
| Regulation text (excerpt) | (3) Ensuring that appropriate corrective actions relating to core CGTP requirements, including reaudits of deficiencies, are taken and documented, as necessary. You must verify corrective actions to ensure that such actions are effective and are in compliance with CGTP. Where appropriate, corrective actions must include both short-term action to address the immediate problem and long-term action to prevent the problem's recurrence. Documentation of corrective actions must include, where… |
At a glance
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- 1–9 Warning letters citing this section
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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.