CFR section
21 CFR 820.80(b): Receiving, in-process, and finished device acceptance
PART 820-QUALITY SYSTEM REGULATION · Subpart H-Acceptance Activities
Key facts
| Citation | 21 CFR 820.80(b) |
|---|---|
| Section | Receiving, in-process, and finished device acceptance |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart H-Acceptance Activities |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. |
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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.