# FDA 483 - Cardinal Health - July 18, 2022

Source: https://www.globalkeysolutions.net/records/483/cardinal-health/bcad7200-af6e-46c8-80bf-6fd8689b9afe

> FDA 483 for Cardinal Health on July 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health
- Inspection Date: 2022-07-18
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Cardinal Health in Mansfield, MA, was inspected and cited for two significant issues related to its quality system for medical devices. The firm failed to adequately control the distribution of finished devices, continuing to ship products associated with recall events without implementing proper hold actions. Additionally, the inspection found that Cardinal Health did not audit suppliers as required by its own procedures, including those linked to product recalls.

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/cardinal-health/dc011bc8-cd35-4d66-ab04-2515d02946d0

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7