# FDA 483 - Argenta US Manufacturing LLC - August 01, 2019

Source: https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/cc66e0cd-37b1-4ff2-8e3b-643c76b103a1

> FDA 483 for Argenta US Manufacturing LLC on August 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argenta US Manufacturing LLC
- Inspection Date: 2019-08-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Bayer Healthcare US, LLC. in Shawnee, KS, revealed two significant deficiencies. The firm failed to adequately retest active pharmaceutical ingredients after extending their retest dates without scientific justification. Additionally, the aseptic processing areas were found to have cracked panel doors, compromising the cleanability and integrity of the sterile environment.

## Related Documents

- [EIR - 2019-08-01](https://www.keypedia.com/records/eir/argenta-us-manufacturing-llc/3c751856-4cce-47be-bcc2-0188ed0805c5)
- [483 - 2022-12-14](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/6f50f0bb-ae80-47bc-aeea-32adbf0905ad)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/51884969-1aac-44e5-8e42-db0251a23cbd)

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

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