# FDA 483 - Chemdex Inc - February 27, 2023

Source: https://www.keypedia.com/records/483/chemdex-inc/d77bc039-84a8-43cc-924e-ff781bf5fc19

> FDA 483 for Chemdex Inc on February 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemdex Inc
- Inspection Date: 2023-02-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Chemdex Inc., an API manufacturer in Lenexa, KS, revealed significant deficiencies across three observations. The firm failed to establish adequate preventative maintenance schedules and cleaning procedures for equipment used in manufacturing Iron Hydrogenated Dextran Bulk Solution 10%. Additionally, the inspection found a lack of proper monitoring and control for microbial counts and endotoxins in water used in final manufacturing steps for a non-sterile API intended for a sterile drug product.

## Related Documents

- [483 - 2025-07-15](https://www.keypedia.com/records/483/chemdex-inc/bb106d2e-9fd9-4466-9ec3-f6dc05044089)

## Related Officers

- [Gretchen L. Trendel](https://www.keypedia.com/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)
- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [Michael Zubelewicz](https://www.keypedia.com/people/michael-zubelewicz/e6dd6fd5-988b-4c7d-bbfb-27a504ae5a03)

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

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