# FDA 483 - Delcath Systems Inc. - June 09, 2023

Source: https://www.keypedia.com/records/483/delcath-systems-inc/15fb5b0b-2b40-469b-98db-cb56aeca0433

> FDA 483 for Delcath Systems Inc. on June 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delcath Systems Inc.
- Inspection Date: 2023-06-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Delcath Systems Inc., a manufacturer of Hepatic Drug Delivery Systems in Queensbury, NY, revealed three significant observations. The firm failed to submit an MDR report for a serious injury, inadequately documented corrective and preventive actions for a sterilization process failure, and lacked clear purchasing data specifications for a critical component. These issues indicate deficiencies in their quality system.

## Related Documents

- [483 - 2013-02-15](https://www.keypedia.com/records/483/delcath-systems-inc/cb671787-35ec-49ac-9a3e-66bb71393c97)

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/delcath-systems-inc/ce3ea8cb-f842-43a9-9eb4-91e58e74932b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961