CFR section
21 CFR 820.160(b): Distribution
PART 820-QUALITY SYSTEM REGULATION · Subpart L-Handling, Storage, Distribution, and Installation
Key facts
| Citation | 21 CFR 820.160(b) |
|---|---|
| Section | Distribution |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart L-Handling, Storage, Distribution, and Installation |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (b) Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (2) The identification and quantity of devices shipped; (3) The date shipped; and (4) Any control number(s) used. |
At a glance
- 10–99 Inspections citing this section
- 10–99 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.