CFR section
21 CFR 820.90(b)(2): Nonconforming product
PART 820-QUALITY SYSTEM REGULATION · Subpart I-Nonconforming Product
Key facts
| Citation | 21 CFR 820.90(b)(2) |
|---|---|
| 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, General |
| Regulation text (excerpt) | (2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR. |
At a glance
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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.