CFR section
21 CFR 820.100(a): Corrective and preventive action
PART 820-QUALITY SYSTEM REGULATION · Subpart J-Corrective and Preventive Action
Key facts
| Citation | 21 CFR 820.100(a) |
|---|---|
| Section | Corrective and preventive action |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart J-Corrective and Preventive Action |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where 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.