# FDA 483 - Delcath Systems Inc. - February 15, 2013

Source: https://www.globalkeysolutions.net/records/483/delcath-systems-inc/cb671787-35ec-49ac-9a3e-66bb71393c97

> FDA 483 for Delcath Systems Inc. on February 15, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delcath Systems Inc.
- Inspection Date: 2013-02-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Delcath Systems Inc. in Queensbury, NY, a combination product manufacturer, revealed significant deficiencies across its quality system. The firm was cited for inadequate design input documentation, insufficient design validation and verification, and failures in process validation. Additionally, issues were noted with statistical techniques, supplier qualification procedures, and the maintenance of device master records.

## Related Documents

- [483 - 2023-06-09](https://www.globalkeysolutions.net/records/483/delcath-systems-inc/15fb5b0b-2b40-469b-98db-cb56aeca0433)

## Related Officers

- [Chad M. Thompson, Investigator](https://www.globalkeysolutions.net/people/chad-m-thompson-investigator/518d91e9-f14e-4a17-b643-bb055e727574)
- [Catherine M. Beer, Investigator](https://www.globalkeysolutions.net/people/catherine-m-beer-investigator/b1899f77-39fb-450c-a507-aae69919f9b2)

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

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