# FDA 483 - Sekisui Medical Co., Ltd. - November 21, 2025

Source: https://www.keypedia.com/records/483/sekisui-medical-co-ltd/d60fd39c-26e5-4382-a570-6770401a164d

> FDA 483 for Sekisui Medical Co., Ltd. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sekisui Medical Co., Ltd.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Sekisui Medical Co., Ltd. in Hachimantai, Japan, an API manufacturer, was cited for failing to perform routine inspection and checking of automatic, mechanical, and electronic equipment. Specifically, the firm did not conduct Installation Qualification (IQ) or Performance Qualification (PQ) for major equipment used in the commercial manufacturing of APIs for the US market. This deficiency led to the release and shipment of unvalidated products to the US market.

## Related Documents

- [483 - 2016-06-17](https://www.keypedia.com/records/483/sekisui-medical-co-ltd/8163dc62-7f2b-448a-a486-963443a0f62b)
- [483 - 2025-11-21](https://www.keypedia.com/records/483/sekisui-medical-co-ltd/ef836792-99e8-464c-8996-1e90b22ce565)

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/sekisui-medical-co-ltd/4dfadeea-0d4e-4543-9dfe-d210f0a51125

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8