# FDA 483 - Titan Kogyo, Ltd. - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/titan-kogyo-ltd/865e2d2d-f8e4-46d3-b278-303ad9413383

> FDA 483 for Titan Kogyo, Ltd. on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Titan Kogyo, Ltd.
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Titan Kogyo, Ltd., an API manufacturer in Ube, Yamaguchi, Japan, revealed significant deficiencies in quality control and manufacturing practices. Observations included the use of raw materials prior to complete testing and release, an inadequate stability program lacking stability-indicating methods, and insufficient verification of raw material supplier Certificates of Analysis. Additionally, equipment and utensils were not adequately cleaned or maintained, posing a risk of contamination to drug substances.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/titan-kogyo-ltd/87e09538-f15e-4bb5-b85a-ded84e50e257

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