CFR section
21 CFR 820.198(c): Complaint files
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.198(c) |
|---|---|
| Section | Complaint files |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart M-Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary. |
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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.