# FDA 483 - CareFusion 303, Inc. - September 06, 2018

Source: https://www.keypedia.com/records/483/carefusion-303-inc/2b146def-bcb7-4763-bebb-47a0f2ecc22d

> FDA 483 for CareFusion 303, Inc. on September 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CareFusion 303, Inc.
- Inspection Date: 2018-09-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CareFusion 303, Inc. in San Diego, CA, a Class-II medical device manufacturer, was inspected regarding its infusion pump products. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including inaccurate complaint data analysis and unverified battery conditioning methods. Additionally, the firm failed to adequately investigate device complaints and demonstrated insufficient design verification for critical pump changes.

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## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)
- [Kirtida Patel](https://www.keypedia.com/people/kirtida-patel/c62852cf-9724-4296-bc4b-de8993dcf716)

Company: https://www.keypedia.com/companies/carefusion-303-inc/e44e5a89-d532-4564-ac5f-1aff2b7d8974

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6