# FDA 483 - Kaneka Corporation Takasago Plant - October 13, 2023

Source: https://www.keypedia.com/records/483/kaneka-corporation-takasago-plant/f2ddbd3e-3dbd-4494-b312-ca04e0285668

> FDA 483 for Kaneka Corporation Takasago Plant on October 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kaneka Corporation Takasago Plant
- Inspection Date: 2023-10-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kaneka Corporation Takasago Plant, an API and Intermediate Manufacturer in Takasago, Hyogo, Japan, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including contamination controls, out-of-specification investigations, analytical method validation, CAPA procedures, reserve sample examination, and water system pathogen evaluation. These issues indicate a moderate to severe level of non-compliance with good manufacturing practices.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.keypedia.com/companies/kaneka-corporation-takasago-plant/c266e629-9a19-4c3d-b8a5-bf27c8f7b7d5

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