FDA 483 - Cayman Chemical Company, Inc. - April 17, 2025

Cayman Chemical Company, Inc. in Ann Arbor, MI, a drug substance manufacturer, was inspected from April 14-17, 2025. The inspection revealed a significant issue concerning data integrity, specifically regarding insufficient controls over computerized systems. Laboratory personnel were found to be capable of altering date and time functions on analytical balances, indicating a potential risk to data reliability.