CFR section
21 CFR 1271.370(b)(4): Labeling
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart E-Additional Requirements for Establishments Described in § 1271.10
Key facts
| Citation | 21 CFR 1271.370(b)(4) |
|---|---|
| Section | Labeling |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart E-Additional Requirements for Establishments Described in § 1271.10 |
| Subchapter | 21 CFR L Other |
| Product types cited | Biologics, Other_Regulations |
| Regulation text (excerpt) | (4) Warnings required under § 1271.60(d)(2), § 1271.65(b)(2), or § 1271.90(c), if applicable and physically possible. If it is not physically possible to include these warnings on the label, the warnings must, instead, accompany the HCT/P. |
At a glance
- 1–9 Inspections citing this section
- None 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.