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

Source: https://www.keypedia.com/records/483/cayman-chemical-company-inc/d1cb0438-079c-4f7e-aa01-320c5a6868ef

> FDA 483 for Cayman Chemical Company, Inc. on April 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cayman Chemical Company, Inc.
- Inspection Date: 2025-04-17
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: 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.

## Related Documents

- [483 - 2018-12-03](https://www.keypedia.com/records/483/cayman-chemical-company-inc/97749715-eccc-4d47-a2ee-292566a496a1)

## Related Officers

- [Melissa M. Steiger](https://www.keypedia.com/people/melissa-m-steiger/513a7364-15df-474f-8a8a-b5c4ff1cf59f)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/cayman-chemical-company-inc/8a9655d6-3cec-4e6e-836e-17e9659f3e5b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03