# FDA 483 - Fresenius Kabi Compounding, LLC - November 05, 2025

Source: https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/5c09f691-6d1d-4edc-88f7-402a9557988e

> FDA 483 for Fresenius Kabi Compounding, LLC on November 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi Compounding, LLC
- Inspection Date: 2025-11-05
- Product Type: drugs
- Office Name: New England District Office
- Summary: Fresenius Kabi Compounding, LLC in Canton, MA, received a Form FDA 483 with seven observations during an inspection from October 9 to November 5, 2025. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, and facility maintenance, particularly concerning defective IV bag ports and procedures to prevent microbiological contamination. These issues indicate a lack of thorough investigation, inadequate adherence to sterile compounding procedures, and poor facility upkeep.

## Related Documents

- [483 - 2018-12-04](https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/0bbbdf26-df86-4894-afe2-2477375da9b3)
- [483 - 2023-03-06](https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/54f3064d-62c9-4860-be8c-da6a97c83835)
- [483 - 2023-03-06](https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/598b5ebf-a623-4891-b57f-bb6f9a0ece91)
- [483 - 2025-10-09](https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/17f338df-0d37-4c23-b79b-5d8790b45902)

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.keypedia.com/companies/fresenius-kabi-compounding-llc/2540f494-15fd-44ca-a889-e238f34ba9fd

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144