# FDA 483 - Baxter Pharmaceutical Solutions, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/c2258424-7ec3-4182-846d-ce66b310826f

> FDA 483 for Baxter Pharmaceutical Solutions, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Pharmaceutical Solutions, LLC
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Baxter Pharmaceutical Solutions LLC, a contract manufacturing organization in Bloomington, IN, received an FDA Form 483 citing significant deficiencies. These included inadequate re-qualification of sterilization processes and documentation for sterile drug products, non-contemporaneous batch record entries, and the absence of a written stability testing program. The firm also failed to thoroughly review batch failures and implement a corrective action plan for recurring complaints of leaking vaccine containers.

## Related Documents

- [483 - 2021-11-10](https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/e58a0478-5a31-4b0c-bf8f-43a2a2cd7673)
- [483 - 2024-02-20](https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/eb37852c-d304-4aa1-b686-b66af3adb296)
- [483 - Unknown Date](https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/18f3a643-f7a3-4880-971e-adfe35384dca)

## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.keypedia.com/companies/baxter-pharmaceutical-solutions-llc/dd8344ef-ad46-49b8-8b39-fb1d8cb518d8

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1