# FDA 483 - Fresenius Kabi Compounding, LLC - March 06, 2023

Source: https://www.keypedia.com/records/483/fresenius-kabi-compounding-llc/54f3064d-62c9-4860-be8c-da6a97c83835

> FDA 483 for Fresenius Kabi Compounding, LLC on March 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi Compounding, LLC
- Inspection Date: 2023-03-06
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Fresenius Kabi Compounding, LLC in Canton, MA, was cited with two observations during an FDA inspection of its outsourcing facility. The firm failed to follow procedures designed to prevent microbiological contamination of sterile drug products, as operators were observed blocking unidirectional airflow in ISO 5 HLFs. Additionally, the accuracy and suitability of test methods for injectable Vancomycin were not established, as USP <71> sterility tests failed to recover a challenge organism, indicating significant concerns regarding sterility assurance and quality control.

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## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94