CFR section
21 CFR 820.200(d): Servicing
PART 820-QUALITY SYSTEM REGULATION · Subpart N-Servicing
Key facts
| Citation | 21 CFR 820.200(d) |
|---|---|
| Section | Servicing |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart N-Servicing |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | (d) Service reports shall be documented and shall include: (1) The name of the device serviced; (2) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used; (3) The date of service; (4) The individual(s) servicing the device; (5) The service performed; and (6) The test and inspection data. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.