# FDA 483 - Corixa Corporation - April 15, 2019

Source: https://www.keypedia.com/records/483/corixa-corporation/51c87378-f6c3-4f62-9aa2-6d03d8d08ac8

> FDA 483 for Corixa Corporation on April 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corixa Corporation
- Inspection Date: 2019-04-15
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Corixa Corporation, a packager and labeler of biological drug products in Marietta, PA, revealed significant deficiencies in their packaging and labeling operations. The firm failed to adequately ensure proper labeling after finishing operations and did not maintain complete investigation records for batch failures. These observations indicate a need for improved quality control and documentation practices.

## Related Officers

- [Bradley E. Benasutti](https://www.keypedia.com/people/bradley-e-benasutti/7a03a364-ad6f-4a80-8504-3fbddc50af58)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/corixa-corporation/0bad1644-f5c6-4021-868f-957b3fec34f6

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8