CFR section
21 CFR 820.80(e): Receiving, in-process, and finished device acceptance
PART 820-QUALITY SYSTEM REGULATION · Subpart H-Acceptance Activities
Key facts
| Citation | 21 CFR 820.80(e) |
|---|---|
| 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, Other_Regulations |
| Regulation text (excerpt) | (e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include: (1) The acceptance activities performed; (2) the dates acceptance activities are performed; (3) the results; (4) the signature of the individual(s) conducting the acceptance activities; and (5) where appropriate the equipment used. These records shall be part of the DHR. |
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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.