# FDA 483 - Baxter Pharmaceutical Solutions, LLC - November 10, 2021

Source: https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/e58a0478-5a31-4b0c-bf8f-43a2a2cd7673

> FDA 483 for Baxter Pharmaceutical Solutions, LLC on November 10, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Baxter Pharmaceutical Solutions, LLC
- Inspection Date: 2021-11-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Baxter Pharmaceuticals Solutions, LLC in Bloomington, IN, revealed significant deficiencies in quality control and facility maintenance. Observations included a failure to thoroughly review unexplained discrepancies in product rejection rates, persistent insect infestation in classified manufacturing areas despite multiple corrective actions, and a lack of adequate authority for the Quality Control unit to fully investigate errors due to restricted access to critical production areas. These issues suggest a systemic breakdown in quality oversight and environmental control.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/c2258424-7ec3-4182-846d-ce66b310826f)
- [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

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Bursell M. Henry, CSO](https://www.keypedia.com/people/bursell-m-henry-cso/0bb31677-e133-4bdd-af39-a7a20f71ad75)
- [Brenton Collins, CSO](https://www.keypedia.com/people/brenton-collins-cso/0dcb7303-2d8b-469c-a595-80b6c2a76099)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0