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# CareFusion 303 FDA-483 Released
- URL: https://www.fdaweb.com/carefusion-303-fda-483-released/
- Published: 2021-01-26T12:00:00.000Z
- Updated: 2026-09-14T16:44:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148527

FDA has released the FDA-483 with eight inspection observations issued following a 3/2-4/6/20 inspection at CareFusion 303, a San Diego, CA, medical device manufacturer. The inspection observations were: 

- failing to adequately establish procedures for corrective and preventive action;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to evaluate and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications;
- failing to report to FDA a device that might present a risk to health;
- failing to adequately establish procedures for design verification;
- failing to implement written medical device reporting procedures;
- failing to adequately establish procedures or instructions for performing servicing activities; and
- validation of device software is incomplete.