# FDA 483 - Chemisphere Corporation - March 17, 2020

Source: https://www.keypedia.com/records/483/chemisphere-corporation/ee024196-3a5f-4880-afb8-ad2b96f87d1f

> FDA 483 for Chemisphere Corporation on March 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemisphere Corporation
- Inspection Date: 2020-03-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Chemisphere Corporation, a pharmaceutical manufacturer in Saint Louis, Missouri, revealed significant deficiencies. Observations included a lack of appropriate controls over computer systems, allowing unauthorized changes and hindering audit trail review, as well as the use of undocumented "Post-It Notes" as raw data. Additionally, the firm's complaint records were found to be deficient, lacking documentation for decisions not to conduct required investigations.

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## Related Officers

- [Alan M. Roberts](https://www.keypedia.com/people/alan-m-roberts/b6565c30-6228-4f51-a1b7-369bffe54e9c)

Company: https://www.keypedia.com/companies/chemisphere-corporation/60ff2ab3-c198-4dea-ab82-539d7bf5fbc0

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