# FDA 483 - TAYCA CORPORATION - December 01, 2023

Source: https://www.globalkeysolutions.net/records/483/tayca-corporation/72668c3b-2759-4c96-a26b-e182744f7871

> FDA 483 for TAYCA CORPORATION on December 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAYCA CORPORATION
- Inspection Date: 2023-12-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Tayca Corporation, an API manufacturer in Okayama, Japan, revealed significant deficiencies in their cleaning validation procedures. The firm failed to periodically verify the effectiveness of validated cleaning procedures for non-dedicated equipment and lacked scientific data to support clean and dirty hold times. These issues indicate a lack of robust quality control in their manufacturing processes.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.globalkeysolutions.net/companies/tayca-corporation/5feb9af2-8ada-4273-829d-2f8397dd1fd4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1