FDA 483 - Chemisphere Corporation - March 17, 2020

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.