# FDA 483 - Argenta US Manufacturing LLC - December 14, 2022

Source: https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/6f50f0bb-ae80-47bc-aeea-32adbf0905ad

> FDA 483 for Argenta US Manufacturing LLC on December 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argenta US Manufacturing LLC
- Inspection Date: 2022-12-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of TriRx Shawnee, LLC, an animal and human drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, lacked adequate procedures to prevent microbiological contamination in sterile products, and did not properly test components for parenteral drugs. These issues indicate a serious lack of adherence to good manufacturing practices.

## Related Documents

- [EIR - 2019-08-01](https://www.keypedia.com/records/eir/argenta-us-manufacturing-llc/3c751856-4cce-47be-bcc2-0188ed0805c5)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/cc66e0cd-37b1-4ff2-8e3b-643c76b103a1)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/51884969-1aac-44e5-8e42-db0251a23cbd)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Gretchen L. Trendel](https://www.keypedia.com/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)
- [Michael Zubelewicz](https://www.keypedia.com/people/michael-zubelewicz/e6dd6fd5-988b-4c7d-bbfb-27a504ae5a03)

Company: https://www.keypedia.com/companies/argenta-us-manufacturing-llc/be369a5c-ac21-4111-897f-1f4983ce11bc

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8