CFR section
21 CFR 820.90(b)(1): Nonconforming product
PART 820-QUALITY SYSTEM REGULATION · Subpart I-Nonconforming Product
Key facts
| Citation | 21 CFR 820.90(b)(1) |
|---|---|
| Section | Nonconforming product |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart I-Nonconforming Product |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use. |
At a glance
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- 10–99 Warning letters citing this section
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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.