CFR section
21 CFR 1271.350(b)(3): Reporting
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 1271.350(b)(3) |
|---|---|
| Section | Reporting |
| 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 | Other_Regulations |
| Regulation text (excerpt) | (3) You must report each such HCT/P deviation that relates to a core CGTP requirement on Form FDA 3486 within 45 days of the discovery of the event either electronically using the Center for Biologics Evaluation and Research electronic Web-based application or by mail to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.