CFR section
21 CFR 820.50(b): Purchasing controls
PART 820-QUALITY SYSTEM REGULATION · Subpart E-Purchasing Controls
Key facts
| Citation | 21 CFR 820.50(b) |
|---|---|
| Section | Purchasing controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart E-Purchasing Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a… |
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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.