# FDA 483 - Fresenius Medical Care Holdings, Inc. - August 02, 2023

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/fd713dbd-7e21-4c47-8a00-477616c5c579

> FDA 483 for Fresenius Medical Care Holdings, Inc. on August 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Medical Care Holdings, Inc.
- Inspection Date: 2023-08-02
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Fresenius Medical Care Holdings, Inc. in Waltham, MA, received a Form FDA 483 for significant quality system deficiencies related to its hemodialysis and peritoneal dialysis machines. The inspection revealed inadequate corrective and preventive action procedures, including delayed investigations into PCB contamination and tubing leaks, and failures in supplier management and design validation. Additionally, the firm conducted an unreported field action to correct devices with PCB-leaching components, indicating a serious lack of regulatory compliance.

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## Related Officers

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

Company: https://www.keypedia.com/companies/fresenius-medical-care-holdings-inc/71c8f1ab-77b5-4c59-ad13-3f0de5b7a6f3

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94