CFR section
21 CFR 820.90(a): Nonconforming product
PART 820-QUALITY SYSTEM REGULATION · Subpart I-Nonconforming Product
Key facts
| Citation | 21 CFR 820.90(a) |
|---|---|
| Section | Nonconforming product |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart I-Nonconforming Product |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any… |
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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.