Cayman Chemical Company, Inc.April 17, 2025

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

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Record Details

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.

Company: Cayman Chemical Company, Inc.
Inspection Date: April 17, 2025
Product Type: Drugs
Office: Detroit District Office
People: Melissa M. Steiger
Jacob G. Lutz (Investigator)

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