# FDA 483 - CareFusion 213, LLC - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/carefusion-213-llc/defb6d8f-9278-4240-a42c-6de4b3d84fec

> FDA 483 for CareFusion 213, LLC on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CareFusion 213, LLC
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: CareFusion 213, LLC in El Paso, TX, a combination drug/device manufacturer, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control unit procedures, raw material testing, component sampling, facility maintenance, and laboratory controls, including a repeat observation regarding sterility test validation. These issues indicate a moderate level of non-compliance with GMP regulations.

## Related Documents

- [483 - 2025-10-24](https://www.globalkeysolutions.net/records/483/carefusion-213-llc/0dd63040-8c20-47db-9d85-1e4c56b007d7)
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- [WARNING_LETTER - 2025-10-24](https://www.globalkeysolutions.net/records/warning_letter/carefusion-213-llc/8435090b-4099-4a47-b8a0-cea87991fb2d)

## Related Officers

- [Oluwasefunmi Agbanigo](https://www.globalkeysolutions.net/people/oluwasefunmi-agbanigo/096acae0-9835-4ff1-8faa-c5ec6f551b21)
- [Rodney L. Tinzie](https://www.globalkeysolutions.net/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/carefusion-213-llc/a1fedbce-120c-4b06-8def-c5a653db579a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab