CFR section
21 CFR 1003.10(a): 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(a) |
|---|---|
| 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) | (a) Immediately notify the Secretary in accordance with § 1003.20, and |
At a glance
- 10–99 Inspections citing this section
- 1–9 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.