# FDA 483 - Baxalta US Inc. - July 01, 2021

Source: https://www.keypedia.com/records/483/baxalta-us-inc/f95e1cd3-4bf4-4cf3-bc61-57698ef46673

> FDA 483 for Baxalta US Inc. on July 01, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxalta US Inc.
- Inspection Date: 2021-07-01
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Baxalta US Inc. in Social Circle, GA, identified two significant issues. The firm failed to maintain complete laboratory records for stability testing, specifically regarding purity determinations for Gammaguard Liquid 10% IGI, and did not report missed stability tests to the Agency. Additionally, procedures for preventing objectionable microorganisms and for remedial cleaning after mold recovery in manufacturing areas for Gammaguard Liquid and Flexbumin were found to be inadequate or not followed.

## Related Officers

- [Yuris G. Blix, CSO](https://www.keypedia.com/people/yuris-g-blix-cso/895b8ce4-5623-444c-b6e1-87050bdfb4eb)
- [Regulatory Project Manager](https://www.keypedia.com/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)
- [Janet L. Brown, CSO](https://www.keypedia.com/people/janet-l-brown-cso/b5f439f3-fcdc-4e90-8eac-64f46964fca9)

Company: https://www.keypedia.com/companies/baxalta-us-inc/dbfac016-3c29-44aa-845b-d79000c4abd2

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7