# FDA 483 - Corixa Corporation d.b.a. GlaxoSmithKline - March 04, 2022

Source: https://www.keypedia.com/records/483/corixa-corporation-dba-glaxosmithkline/66b7f6dc-5234-4cb2-9241-fd571a6609fb

> FDA 483 for Corixa Corporation d.b.a. GlaxoSmithKline on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corixa Corporation d.b.a. GlaxoSmithKline
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Corixa Corporation d.b.a. GlaxoSmithKline in Marietta, PA, a drug manufacturer, received a Form 483 with two observations. The inspection found deficiencies in packaging facility line clearance procedures, resulting in materials from previous batches remaining on the line. Additionally, investigations into batch failures lacked complete conclusions and follow-up, specifically regarding the assessment of impacted products.

## Related Officers

- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)
- [Pankaj Amin, CSO](https://www.keypedia.com/people/pankaj-amin-cso/d01a4c72-08cd-409e-99bc-3e54afcbd17a)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/corixa-corporation-dba-glaxosmithkline/073e79ff-24d9-475f-980f-49be864eeef8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd