CFR section
21 CFR 820.200(c): Servicing
PART 820-QUALITY SYSTEM REGULATION · Subpart N-Servicing
Key facts
| Citation | 21 CFR 820.200(c) |
|---|---|
| Section | Servicing |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart N-Servicing |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198. |
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.