# FDA 483 - XGen Pharmaceuticals DJB, Inc. - June 14, 2024

Source: https://www.globalkeysolutions.net/records/483/xgen-pharmaceuticals-djb-inc/62589896-47b7-4d27-a184-96ef9c6e9dff

> FDA 483 for XGen Pharmaceuticals DJB, Inc. on June 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: XGen Pharmaceuticals DJB, Inc.
- Inspection Date: 2024-06-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of XGen Pharmaceuticals DJB, Inc. in Horseheads, NY, revealed significant deficiencies in their handling and reporting of post-marketing adverse drug experiences. Observations included a lack of written procedures for initial receipt dates, incomplete patient information in Individual Case Safety Reports (ICSRs), and failures to submit safety reports electronically. Additionally, the firm incorrectly identified reporters in expedited ICSRs from scientific literature.

## Related Documents

- [483 - 2019-08-22](https://www.globalkeysolutions.net/records/483/xgen-pharmaceuticals-djb-inc/3e08ac8d-052b-42e4-b0c1-dcb1a49b7848)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.globalkeysolutions.net/companies/xgen-pharmaceuticals-djb-inc/42cd8012-b30d-440e-b2c7-e0d2915c417a

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