21 CFR 820.50: Purchasing controls
Required manufacturers to maintain procedures ensuring purchased products and services met specified requirements, including documented evaluation and selection of suppliers, defined control levels, records of acceptable suppliers, and approved purchasing data describing requirements and change-noti
Part 820, Quality System Regulation · Subpart E, Purchasing Controls
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.50, from the 483s we hold.
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.Most used
The evaluation of potential suppliers was not documented.820.50(a)
Records of acceptable suppliers have not been adequately established.820.50(a)
Cited over time
483s citing 820.50, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 820.50
- Nanovis LLC · Columbia City, IndianaPurchasing information does not adequately descrit e or reference the product to be… Mar 19, 2026
- Helios Cardio Inc. · —Outsourced processes that affect product conformity to requirements were not… Mar 6, 2026
- Seniorlife Technologies Inc · Bellevue, WashingtonOutsourced processes that affect product conformity to requirements were not… Feb 20, 2026
- MIDWAY MEDICAL · Bloomington, IllinoisProcedures to ensure that all purchased or otherwise received product and services… Jan 15, 2026
- SMC · —Specifically, justification documented. There is no agreement with suppliers to… Dec 11, 2025
The regulation text
§ 820.50 Purchasing controls. As published before it was replaced.
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a)Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1)Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2)Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3)Establish and maintain records of acceptable suppliers, contractors, and consultants.
(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 finished device. Purchasing data shall be approved in accordance with § 820.40.
Questions
What does 21 CFR 820.50 require?
Required manufacturers to maintain procedures ensuring purchased products and services met specified requirements, including documented evaluation and selection of suppliers, defined control levels, records of acceptable suppliers, and approved purchasing data describing requirements and change-noti
How do FDA investigators word a 820.50 observation?
The most common opening is: “Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.”
Which sections are cited alongside 820.50?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.22 (Quality audit).