# FDA 483 - Fresenius Kabi USA, LLC - August 30, 2023

Source: https://www.globalkeysolutions.net/records/483/fresenius-kabi-usa-llc/91efc984-74c0-4435-9a5c-15f4efbc26a7

> FDA 483 for Fresenius Kabi USA, LLC on August 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2023-08-30
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Fresenius Kabi USA, LLC, a medical device manufacturer in Grand Island, NY, revealed deficiencies in their corrective and preventive action (CAPA) procedures. The firm's CAPA process allows for actions to not include verification or validation of effectiveness under certain conditions, and two out of five reviewed CAPAs lacked this crucial step.

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## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/fresenius-kabi-usa-llc/f0c47fa1-3b76-4e6c-82dd-d703086bdfdc

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d