CFR section
21 CFR 1003.10(b): Discovery of defect or failure of compliance by manufacturer; notice requirements
PART 1003-NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY · Subpart B-Discovery of Defect or Failure To Comply
Key facts
| Citation | 21 CFR 1003.10(b) |
|---|---|
| Section | Discovery of defect or failure of compliance by manufacturer; notice requirements |
| Part | PART 1003-NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY |
| Subpart | Subpart B-Discovery of Defect or Failure To Comply |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the following persons: (1) The dealers or distributors to whom such product was delivered by the manufacturer; and (2) The purchaser of such product and any subsequent transferee of such product (where known to the manufacturer or where the manufacturer upon reasonable inquiry to dealers, distributors, or purchasers can identify the present user). |
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.