# FDA 483 - Fresenius Medical Care, North America - May 21, 2021

Source: https://www.globalkeysolutions.net/records/483/fresenius-medical-care-north-america/e6d7cf63-c9b4-419b-8dad-1febdcab29cf

> FDA 483 for Fresenius Medical Care, North America on May 21, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fresenius Medical Care, North America
- Inspection Date: 2021-05-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Fresenius Medical Care, North America in Ogden, UT, from May 19-21, 2021, revealed a significant deficiency in the firm's investigation processes. The company failed to conduct comprehensive investigations into numerous patient complaints regarding leakage of their Delflex Peritoneal Dialysis Sterile Solution bags. This indicates a serious lapse in quality control and root cause analysis for a critical medical product.

## Related Documents

- [WARNING_LETTER - 2012-12-07](https://www.globalkeysolutions.net/records/warning_letter/fresenius-medical-care-north-america/13ad9f83-444c-496f-9ebe-aabaadfbd30b)
- [483 - 2020-08-13](https://www.globalkeysolutions.net/records/483/fresenius-medical-care-north-america/f722a98a-9b92-40b1-8c0a-5c07ebf6c6a6)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.globalkeysolutions.net/companies/fresenius-medical-care-north-america/90cbe724-7310-49e8-983b-b062488d9710

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