CFR section
21 CFR 820.198(a): Complaint files
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.198(a) |
|---|---|
| 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) | (a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this… |
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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.