CFR section
21 CFR 820.198(g): Complaint files
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.198(g) |
|---|---|
| Section | Complaint files |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart M-Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either: (1) A location in the United States where the manufacturer's records are regularly kept; or (2) The location of the initial distributor. |
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.