# FDA 483 - Cayman Chemical Company, Inc. - December 03, 2018

Source: https://www.globalkeysolutions.net/records/483/cayman-chemical-company-inc/97749715-eccc-4d47-a2ee-292566a496a1

> FDA 483 for Cayman Chemical Company, Inc. on December 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cayman Chemical Company, Inc.
- Inspection Date: 2018-12-03
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Cayman Chemicals Company, Inc. in Ann Arbor, MI, conducted from November 27 to December 3, 2018, identified a significant quality control deficiency. The firm failed to perform required growth promotion testing on growth media used for environmental monitoring during API packaging activities. This indicates a potential risk to product quality and environmental control.

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## Related Officers

- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

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

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