# FDA 483 - Chemdex Inc - July 15, 2025

Source: https://www.globalkeysolutions.net/records/483/chemdex-inc/bb106d2e-9fd9-4466-9ec3-f6dc05044089

> FDA 483 for Chemdex Inc on July 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemdex Inc
- Inspection Date: 2025-07-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Chemdex Inc. in Lenexa, KS, revealed a critical failure in the quality unit's oversight of cleaning and maintenance systems for equipment used in manufacturing sterile drug products. Specifically, cleaning validation studies did not address microbiological or endotoxin contamination, and processes for reviewing reactor inspections and addressing recommended maintenance were not established. These issues pose a risk to the sterility and quality of their drug products.

## Related Documents

- [483 - 2023-02-27](https://www.globalkeysolutions.net/records/483/chemdex-inc/d77bc039-84a8-43cc-924e-ff781bf5fc19)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)
- [Consumer Safety Officer, FDA](https://www.globalkeysolutions.net/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)

Company: https://www.globalkeysolutions.net/companies/chemdex-inc/5a2f062f-a976-4769-b7a8-2f6180d03833

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