Purchasing Controls / Supplier Management

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  equirements, including quality requirements, that must be met by suppliers, contractors, and consultants.

Avoid FDA 483: Failed to implement its established procedures for purchasing controls.                                                                                      Avoid FDA 483: Failed to establish and maintain the requirements that must be met by suppliers, contractors, and consultants. Failed to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR 820.50(a).